Physiological monitoring apparatus

ABSTRACT

An earpiece module includes a physiological sensor, an external energy sensor, a transceiver, a communication module, a data storage component, and a power source. The communication module includes a microphone, a speaker, and a signal processor. The signal processor processes audio information received from a remote source via the transceiver and communicates the processed audio information to a subject via the speaker. The signal processor processes information in real time from the physiological sensor and the external energy sensor, and the signal processor provides biofeedback to the subject based on signals produced by the physiological sensor. The data storage component includes a plurality of algorithms. At least one algorithm focuses processing resources on extracting physiological information from the physiological sensor, at least one algorithm is configured to be modified or uploaded wirelessly via the transceiver, and at least one algorithm is a compression/decompression (CODEC) algorithm.

RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 14/063,669, filed Oct. 25, 2013, which is acontinuation application of U.S. patent application Ser. No. 11/811,844,filed Jun. 12, 2007, now U.S. Pat. No. 8,652,040, and which claims thebenefit of and priority to U.S. Provisional Patent Application No.60/905,761, filed Mar. 8, 2007, U.S. Provisional Patent Application No.60/876,128, filed Dec. 21, 2006, and U.S. Provisional Patent ApplicationNo. 60/875,606, filed Dec. 19, 2006, the disclosures of which areincorporated herein by reference as if set forth in their entireties.

FIELD OF THE INVENTION

The present invention relates generally to health and environmentalmonitors and, more particularly, to wireless health and environmentmonitors.

BACKGROUND OF THE INVENTION

There is growing market demand for personal health and environmentalmonitors, for example, for gauging overall health and metabolism duringexercise, athletic training, dieting, and physical therapy. However,traditional health monitors and environmental monitors may be bulky,rigid, and uncomfortable—generally not suitable for use during dailyphysical activity. There is also growing interest in generating andcomparing health and environmental exposure statistics of the generalpublic and particular demographic groups. For example, collectivestatistics enable the healthcare industry and medical community todirect healthcare resources to where they are most highly valued.However, methods of collecting these statistics may be expensive andlaborious, often utilizing human-based recording/analysis steps atmultiple sites.

As such, improved ways of collecting, storing and analyzing personalhealth and environmental information are needed. In addition, improvedways of distributing raw and analyzed personal health and environmentalinformation are desirable to support efforts to enhance healthcarequality and reduce costs.

SUMMARY

In view of the above discussion, apparatus for monitoring variousphysiological and environmental factors are provided. According to someembodiments of the present invention, real-time, noninvasive health andenvironmental monitors include a plurality of compact sensors integratedwithin small, low-profile devices. Physiological and environmental datais collected and wirelessly transmitted into a wireless network, wherethe data is stored and/or processed.

In some embodiments of the invention, an earpiece functions as aphysiological monitor, an environmental monitor, and a wireless personalcommunicator. The earpiece can take advantage of commercially availableopen-architecture wireless paradigms, such as Bluetooth®, Wi-Fi, orZigBee. In some embodiments, a small, compact earpiece contains at leastone microphone and one speaker, and is configured to transmitinformation wirelessly to a recording device such as, for example, acell phone, a personal digital assistant (PDA), and/or a computer. Theearpiece contains a plurality of sensors for monitoring personal healthand environmental exposure. Health and environmental information, sensedby the sensors is transmitted wirelessly, in real-time, to a recordingdevice, capable of processing and organizing the data into meaningfuldisplays, such as charts. In some embodiments, an earpiece user canmonitor health and environmental exposure data in real-time, and mayalso access records of collected data throughout the day, week, month,etc., by observing charts and data through an audio-visual display.

In some embodiments, an earpiece can integrate personal physiologicaland environmental exposure information with biofeedback and personalentertainment. In other embodiments of the present invention, earpiecemonitor devices enable a variety of networks, applications, games, andbusiness methods.

In some embodiments of the present invention, a monitoring apparatusincludes a housing configured to be attached to the body of a person,one or more physiological sensors and one or more environmental sensorssupported by (within and/or on) the housing. Each physiological sensoris configured to detect and/or measure physiological information fromthe person, and each environmental sensor is configured to detect and/ormeasure environmental conditions in a vicinity of the person wearing theapparatus. The apparatus also includes a signal processor that isconfigured to receive and process signals produced by the physiologicaland environmental sensors. A wireless transmitter is responsive to thesignal processor and is configured to wirelessly transmit physiologicaland environmental sensor signals as processed by the signal processorfrom the signal processor to a remote terminal in real-time.

Each physiological sensor is configured to detect and/or measure one ormore of the following types of physiological information: heart rate,pulse rate, breathing rate, blood flow, heartbeat signatures,cardio-pulmonary health, organ health, metabolism, electrolyte typeand/or concentration, physical activity, caloric intake, caloricmetabolism, blood metabolite levels or ratios, blood pH level, physicaland/or psychological stress levels and/or stress level indicators, drugdosage and/or dosimetry, physiological drug reactions, drug chemistry,biochemistry, position and/or balance, body strain, neurologicalfunctioning, brain activity, brain waves, blood pressure, cranialpressure, hydration level, auscultatory information, auscultatorysignals associated with pregnancy, physiological response to infection,skin and/or core body temperature, eye muscle movement, blood volume,inhaled and/or exhaled breath volume, physical exertion, exhaled breathphysical and/or chemical composition, the presence and/or identityand/or concentration of viruses and/or bacteria, foreign matter in thebody, internal toxins, heavy metals in the body, anxiety, fertility,ovulation, sex hormones, psychological mood, sleep patterns, hungerand/or thirst, hormone type and/or concentration, cholesterol, lipids,blood panel, bone density, organ and/or body weight, reflex response,sexual arousal, mental and/or physical alertness, sleepiness,auscultatory information, response to external stimuli, swallowingvolume, swallowing rate, sickness, voice characteristics, voice tone,voice pitch, voice volume, vital signs, head tilt, allergic reactions,inflammation response, auto-immune response, mutagenic response, DNA,proteins, protein levels in the blood, water content of the blood,pheromones, internal body sounds, digestive system functioning, cellularregeneration response, healing response, stem cell regeneration response

Each environmental sensor is configured to detect and/or measure one ormore of the following types of environmental information: climate,humidity, temperature, pressure, barometric pressure, soot density,airborne particle density, airborne particle size, airborne particleshape, airborne particle identity, volatile organic chemicals (VOCs),hydrocarbons, polycyclic aromatic hydrocarbons (PAHs), carcinogens,toxins, electromagnetic energy, optical radiation, X-rays, gamma rays,microwave radiation, terahertz radiation, ultraviolet radiation,infrared radiation, radio waves, atomic energy alpha particles, atomicenergy beta-particles, gravity, light intensity, light frequency, lightflicker, light phase, ozone, carbon monoxide, carbon dioxide, nitrousoxide, sulfides, airborne pollution, foreign material in the air,viruses, bacteria, signatures from chemical weapons, wind, airturbulence, sound and/or acoustical energy, ultrasonic energy, noisepollution, human voices, animal sounds, diseases expelled from others,exhaled breath and/or breath constituents of others, toxins from others,pheromones from others, industrial and/or transportation sounds,allergens, animal hair, pollen, exhaust from engines, vapors and/orfumes, fuel, signatures for mineral deposits and/or oil deposits, snow,rain, thermal energy, hot surfaces, hot gases, solar energy, hail, ice,vibrations, traffic, the number of people in a vicinity of the person,coughing and/or sneezing sounds from people in the vicinity of theperson, loudness and/or pitch from those speaking in the vicinity of theperson.

In some embodiments, the signal processor is configured to processsignals produced by the physiological and environmental sensors intosignals that can be heard and/or viewed by the person wearing theapparatus. In some embodiments, the signal processor is configured toselectively extract environmental effects from signals produced by aphysiological sensor and/or selectively extract physiological effectsfrom signals produced by an environmental sensor.

In some embodiments of the present invention, a monitoring apparatusconfigured to be worn by a person includes a physiological sensor thatis oriented in a direction towards the person and an environmentalsensor that is oriented in a direction away from the person. A buffermaterial is positioned between the physiological sensor andenvironmental sensors and is configured to selectively reflect and/orabsorb energy emanating from the environment and/or the person.

In some embodiments of the present invention, a monitoring apparatus mayinclude a receiver that is configured to receive audio and/or videoinformation from a remote terminal, and a communication module that isconfigured to store and/or process and/or play audio and/or videoinformation received from the remote terminal. In some embodiments, thecommunication module may be configured to alert (e.g., via audibleand/or visible and/or physical alerts) a person wearing the apparatuswhen a physiological sensor detects certain physiological informationfrom the person and/or when an environmental sensor detects certainenvironmental information from the vicinity of the person. In someembodiments, the communication module is configured to audibly presentvital sign information to the person wearing the apparatus. In someembodiments, the communication module may be configured to store contentgenerated by the person.

In some embodiments of the present invention, a monitoring apparatus mayinclude a transmitter that is configured to transmit signals produced byphysiological and environmental sensors associated therewith to a gamingdevice. The monitoring apparatus may also be configured to receivefeedback regarding monitored health and environmental parameters. Assuch, personal health and environmental feedback can be an activecomponent of a game.

In some embodiments, the apparatus is an earpiece module that isconfigured to be attached to the ear of a person, and includes aspeaker, microphone, and transceiver that is electronically connected tothe speaker and microphone and that permits bidirectional wirelesscommunications between the earpiece module and a remote terminal, suchas a cell phone. The transceiver (e.g., a Bluetooth®, Wi-Fi, or ZigBeetransceiver) is electronically connected to the signal processor and isconfigured to transmit physiological and environmental sensor signalsfrom the signal processor to the remote terminal. In some embodiments,the earpiece module may include an arm that is attached to the housingand that supports the microphone. The arm may be movable between astored position and an extended, operative position. The arm may alsoinclude one or more physiological sensor and/or environmental sensors.

In some embodiments of the present invention, an earpiece module that isconfigured to be attached to the ear of a person includes a firstacoustical sensor oriented in a direction towards a tympanic membrane ofthe ear and is configured to detect acoustical energy emanating from thetympanic membrane. A second acoustical sensor is oriented in a directionaway from the person. The signal processor is configured to utilizesignals produced by the second acoustical signal to extractenvironmental acoustical energy not emanating from the tympanic membranefrom signals produced by the first acoustical sensor. In someembodiments, the earpiece module may include an optical emitter thatdirects optical energy towards the tympanic membrane, and an opticaldetector that is configured to detect secondary optical energy emanatingfrom the tympanic membrane. The signal processor is configured toextract selected optical energy from the secondary optical energyemanating from the tympanic membrane. The signal processor may also beconfigured to extract optical noise from the secondary optical energyemanating from the tympanic membrane. In some embodiments, the opticaldetector may include a filter configured to pass secondary opticalenergy at selective wavelengths.

In some embodiments of the present invention, an earpiece module that isconfigured to be attached to the ear of a person includes an opticaldetector that is configured to detect acoustically modulated blackbodyIR radiation emanating from the tympanic membrane.

In some embodiments of the present invention, an earpiece module that isconfigured to be attached to the ear of a person includes an opticalemitter that directs optical energy towards the tympanic membrane, andan optical detector configured to detect secondary optical energyemanating from the tympanic membrane. In some embodiments, the signalprocessor may be configured to extract selected optical energy and/oroptical noise from the secondary optical energy emanating from thetympanic membrane. In some embodiments, the optical detector may includea filter configured to pass secondary optical energy at selectivewavelengths.

In some embodiments of the present invention, an earpiece module that isconfigured to be attached to the ear of a person includes an ear hookthat is configured to attach to an ear of a person. One or morephysiological sensors and/or one or more environmental sensors may besupported by the ear hook. In some embodiments, the hook may include apinna cover that is configured to contact a portion of the pinna of anear. One or more physiological and/or environmental sensors may besupported by the pinna cover.

In some embodiments of the present invention, an earpiece module mayinclude an arm that extends outwardly therefrom and that supports one ormore physiological sensors and/or environmental sensors. For example,the arm may be configured to support physiological sensors configured todetect and/or measure jaw motion and/or arterial blood flow near theneck of a person wearing the earpiece module.

In some embodiments of the present invention, an earpiece module mayinclude an earpiece fitting configured to be inserted near or within theear canal of a person wearing the earpiece. The earpiece fitting mayinclude one or more physiological sensors configured to detectinformation from within the ear canal.

In some embodiments of the present invention, an earpiece module mayinclude a transmittance pulse oximeter and/or reflectance pulseoximeter. For example, the earpiece module may include an earlobe cliphaving a transmittance pulse oximeter and/or reflectance pulse oximetersupported thereby. As another example, the earpiece module may include atransmitter pulse oximeter and/or reflectance pulse oximeter supportedat the front or back of the ear.

In some embodiments of the present invention, a monitoring apparatus isan earring. The earring may be configured to operate independently ofother monitoring apparatus, such as an earpiece module, or may operatein conjunction with another monitoring apparatus. For example, anearring may include one or more physiological sensors configured todetect and/or measure physiological information from the person, and oneor more environmental sensors configured to detect and/or measureenvironmental conditions in a vicinity of the person wearing theearring. The earring may also include a signal processor that receivesand processes signals produced by the physiological and environmentalsensors, and a transmitter that transmits physiological andenvironmental sensor signals from the signal processor to a remoteterminal in real-time.

In some embodiments of the present invention, a monitoring apparatusconfigured to be attached to the ear of a person may include a housingcontaining one or more physiological and environmental sensors whereinthe housing is configured to be positioned in adjacent contactingrelationship with the temple of the person.

Monitoring apparatus, according to some embodiments of the presentinvention, may include various additional devices/features. For example,a monitoring apparatus may include an air sampling system that samplesair in a vicinity of the person wearing the apparatus. In someembodiments, one or more physiological sensors in a monitoring apparatusmay be configured to detect drowsiness of the person wearing theapparatus. An alarm may be provided that is configured to alert theperson in response to one or more physiological sensors detectingdrowsiness. In some embodiments, a monitoring apparatus may include auser interface that provides user control over one or more of thephysiological and/or environmental sensors. A user interface may beprovided on the monitoring apparatus or may be included on a remotedevice in wireless communication with the monitoring apparatus. In someembodiments, a monitoring apparatus may include a user interface that isconfigured to allow the person to store a time mark indicating aparticular point in time.

Monitoring apparatus, according to some embodiments of the presentinvention, may be configured to send a signal to a remote terminal whenone or more of the physiological and/or environmental sensors are turnedoff by a user and/or when one or more of the physiological and/orenvironmental sensors malfunction or fail. In some embodiments, a signalmay be sent to a remote terminal when potentially erroneous data hasbeen collected by one or more of the physiological and/or environmentalsensors, such as when a person wearing a monitoring apparatus issurrounded by loud noises.

Monitoring apparatus, according to some embodiments of the presentinvention, may be configured to detect damage to a portion of the bodyof the person wearing the apparatus, and may be configured to alert theperson when such damage is detected. For example, when a person isexposed to sound above a certain level that may be potentially damaging,the person is notified by the apparatus to move away from the noisesource. As another example, the person may be alerted upon damage to thetympanic membrane due to loud external noises.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a telemetric earpiece module forphysiological and environmental monitoring and personal communication,according to some embodiments of the present invention.

FIG. 2 is a block diagram of a telemetric network for health andenvironmental monitoring through portable telemetric sensor modules,such as the earpiece module of FIG. 1, according to some embodiments ofthe present invention.

FIG. 3 illustrates a graphical user interface for displaying data,according to some embodiments of the present invention.

FIG. 4 is a block diagram that illustrates a method of extractingphysiological and environmental information using a plurality of sensorsand a signal processor, according to some embodiments of the presentinvention.

FIG. 5 illustrates an auscultatory signal extraction technique accordingto the methodology illustrated in FIG. 4.

FIG. 6 illustrates an optical physiological signal extraction technique,according to some embodiments of the present invention, and whereinoptical information scattered from the tympanic membrane is digitallycompared with acoustical energy from the environment to generate anextracted signal containing cleaner physiological information than rawoptical information scattered from the tympanic membrane.

FIG. 7 illustrates an optical source detector configuration, accordingto some embodiments of the present invention, for the physiologicalsignal extraction method illustrated in FIG. 6.

FIG. 8 illustrates experimental auscultatory data obtained via theauscultatory signal extraction approach of FIG. 5.

FIG. 9 illustrates an earpiece module according to some embodiments ofthe present invention.

FIG. 10 is a side view of the earpiece module of FIG. 9 showing aplacement of physiological sensors, according to some embodiments of thepresent invention.

FIG. 11 is a front view of the earpiece module of FIG. 9 showing aplacement of environmental sensors, according to some embodiments of thepresent invention.

FIG. 12 is an exploded view of the earpiece module of FIG. 9 showing alocation of various physiological sensors, according to some embodimentsof the present invention.

FIG. 13 is a side view of a flexible substrate configured to placesensors in selected locations in the vicinity of the ear, according tosome embodiments of the present invention.

FIGS. 14A-14B illustrates an earpiece module with an adjustablemouthpiece for monitoring physiological and environmental informationnear the mouth, according to some embodiments of the present invention,wherein FIG. 14A illustrates the mouthpiece in a stored position andwherein FIG. 14B illustrates the mouthpiece in an extended operativeposition.

FIG. 15 illustrates an earpiece module incorporating variousphysiological and environmental sensors, according to some embodimentsof the present invention, and being worn by a user.

FIG. 16 illustrates an earpiece module according to other embodiments ofthe present invention that includes a temple module for physiologicaland environmental monitoring.

FIG. 17 illustrates a pulse-oximeter configured to be attached to an earof a user and that may be incorporated into an earpiece module,according to some embodiments of the present invention. The illustratedpulse-oximeter is in transmission mode.

FIG. 18 illustrates a pulse-oximeter configured to be integrated into anearpiece module, according to some embodiments of the present invention.The illustrated pulse-oximeter is in reflection mode.

FIG. 19 illustrates a sensor module having a plurality of health andenvironmental sensors and mounted onto a Bluetooth headset module,according to some embodiments of the present invention.

FIG. 20 is a pie chart that graphically illustrates exemplary powerusage of an earpiece module for monitoring health and environmentalexposure, according to some embodiments of the present invention.

DETAILED DESCRIPTION

The present invention now is described more fully hereinafter withreference to the accompanying drawings, in which preferred embodimentsof the invention are shown. This invention may, however, be embodied inmany different forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

Like numbers refer to like elements throughout. In the figures, thethickness of certain lines, layers, components, elements or features maybe exaggerated for clarity.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

It will be understood that when an element is referred to as being “on”,“attached” to, “connected” to, “coupled” with, “contacting”, etc.,another element, it can be directly on, attached to, connected to,coupled with or contacting the other element or intervening elements mayalso be present. In contrast, when an element is referred to as being,for example, “directly on”, “directly attached” to, “directly connected”to, “directly coupled” with or “directly contacting” another element,there are no intervening elements present. It will also be appreciatedby those of skill in the art that references to a structure or featurethat is disposed “adjacent” another feature may have portions thatoverlap or underlie the adjacent feature.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if the device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of “over” and “under”. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

The term “earpiece module” includes any type of device that may beattached to or near the ear of a user and may have variousconfigurations, without limitation.

The term “real-time” is used to describe a process of sensing,processing, or transmitting information in a time frame which is equalto or shorter than the minimum timescale at which the information isneeded. For example, the real-time monitoring of pulse rate may resultin a single average pulse-rate measurement every minute, averaged over30 seconds, because an instantaneous pulse rate is often useless to theend user. Typically, averaged physiological and environmentalinformation is more relevant than instantaneous changes. Thus, in thecontext of the present invention, signals may sometimes be processedover several seconds, or even minutes, in order to generate a“real-time” response.

The term “monitoring” refers to the act of measuring, quantifying,qualifying, estimating, sensing, calculating, interpolating,extrapolating, inferring, deducing, or any combination of these actions.More generally, “monitoring” refers to a way of getting information viaone or more sensing elements. For example, “blood health monitoring”includes monitoring blood gas levels, blood hydration, andmetabolite/electrolyte levels.

The term “physiological” refers to matter or energy of or from the bodyof a creature (e.g., humans, animals, etc.). In embodiments of thepresent invention, the term “physiological” is intended to be usedbroadly, covering both physical and psychological matter and energy ofor from the body of an organism. However, in some cases, the term“psychological” is called-out separately to emphasize aspects ofphysiology that are more closely tied to conscious or subconscious brainactivity rather than the activity of other organs, tissues, or cells.

The term “psychosocial stress” refers to events of psychological orsocial origin which challenge the homeostatic state of biologicalsystems.

The term “body” refers to the body of a person (or animal) that mayutilize an earpiece module according to embodiments of the presentinvention. Monitoring apparatus, according to embodiments of the presentinvention may be worn by humans and animals.

In the following figures, earpiece modules will be illustrated anddescribed for attachment to the ear of the human body. However, it is tobe understood that embodiments of the present invention are not limitedto those worn by humans. Moreover, monitoring apparatus according toembodiments of the present invention are not limited to earpiece modulesand/or devices configured to be attached to or near the ear. Monitoringapparatus according to embodiments of the present invention may be wornon various parts of the body.

Some embodiments of the present invention may arise from a discoverythat the ear is an ideal location on the human body for a wearablehealth and environmental monitor. The ear is a relatively immobileplatform that does not obstruct a person's movement or vision. Deviceslocated along the ear have access to the inner-ear canal and tympanicmembrane (for measuring core body temperature), muscle tissue (formonitoring muscle tension), the pinna and earlobe (for monitoring bloodgas levels), the region behind the ear (for measuring skin temperatureand galvanic skin response), and the internal carotid artery (formeasuring cardiopulmonary functioning). The ear is also at or near thepoint of exposure to: environmental breathable toxicants of interest(volatile organic compounds, pollution, etc.; noise pollutionexperienced by the ear; and lighting conditions for the eye.Furthermore, as the ear canal is naturally designed for transmittingacoustical energy, the ear provides an optimal location for monitoringinternal sounds, such as heartbeat, breathing rate, and mouth motion.

Bluetooth-enabled and/or other personal communication earpiece modulesmay be configured to incorporate physiological and/or environmentalsensors, according to some embodiments of the present invention.Bluetooth earpiece modules are typically lightweight, unobtrusivedevices that have become widely accepted socially. Moreover, Bluetoothearpiece modules are cost effective, easy to use, and are often worn byusers for most of their waking hours while attending or waiting for cellphone calls. Bluetooth earpiece modules configured according toembodiments of the present invention are advantageous because theyprovide a function for the user beyond health monitoring, such aspersonal communication and multimedia applications, thereby encouraginguser compliance. Exemplary physiological and environmental sensors thatmay be incorporated into a Bluetooth or other type of earpiece moduleinclude, but are not limited to accelerometers, auscultatory sensors,pressure sensors, humidity sensors, color sensors, light intensitysensors, pressure sensors, etc.

Wireless earpiece devices incorporating low-profile sensors and otherelectronics, according to embodiments of the present invention, offer aplatform for performing near-real-time personal health and environmentalmonitoring in wearable, socially acceptable devices. The capability tounobtrusively monitor an individual's physiology and/or environment,combined with improved user compliance, is expected to have significantimpact on future planned health and environmental exposure studies. Thisis especially true for those that seek to link environmental stressorswith personal stress level indicators. The large scale commercialavailability of this low-cost device can enable cost-effective largescale studies. The combination of monitored data with user location viaGPS data can make on-going geographic studies possible, including thetracking of infection over large geographic areas. The commercialapplication of the proposed platform encourages individual-driven healthmaintenance and promotes a healthier lifestyle through proper caloricintake and exercise.

Accordingly, some embodiments of the present invention combine apersonal communications earpiece device with one or more physiologicaland/or environmental sensor. Other embodiments may combine physiologicaland/or environmental sensors into an earpiece device.

Embodiments of the present invention are not limited to devices thatcommunicate wirelessly. In some embodiments of the present invention,devices configured to monitor an individual's physiology and/orenvironment may be wired to a device that stores and/or processes data.In some embodiments, this information may be stored on the earpiecemodule itself.

FIG. 1 is a block diagram illustrating an earpiece module 100, accordingto some embodiments of the present invention. The illustrated earpiecemodule 100 includes one or more of the following: at least onephysiological sensor 101, at least one environmental sensor 102 (alsoreferred to as an external energy sensor), at least one signal processor103, at least one transmitter/receiver 104, at least one power source106, at least one communication & entertainment module 107, at least oneearpiece attachment component 105, and at least one housing 108. Thoughthe health and environmental sensor functionality can be obtainedwithout the communication and entertainment module 107, having thisadditional module may promote use of the earpiece module 100 by users.The illustrated earpiece module 100 is intended primarily for human use;however, the earpiece module 100 may also be configured for use withother animals having ears sufficient to support an earpiece, such asprimates, canines, felines, cattle, and most other mammals.

A physiological sensor 101 can be any compact sensor for monitoring thephysiological functioning of the body, such as, but not limited to,sensors for monitoring: heart rate, pulse rate, breathing rate, bloodflow, heartbeat signatures, cardio-pulmonary health, organ health,metabolism, electrolyte type and concentration, physical activity,caloric intake, caloric metabolism, metabolomics, physical andpsychological stress levels and stress level indicators, physiologicaland psychological response to therapy, drug dosage and activity (drugdosimetry), physiological drug reactions, drug chemistry in the body,biochemistry, position & balance, body strain, neurological functioning,brain activity, brain waves, blood pressure, cranial pressure, hydrationlevel, auscultatory information, auscultatory signals associated withpregnancy, physiological response to infection, skin and core bodytemperature, eye muscle movement, blood volume, inhaled and exhaledbreath volume, physical exertion, exhaled breath physical and chemicalcomposition, the presence, identity, and concentration of viruses &bacteria, foreign matter in the body, internal toxins, heavy metals inthe body, anxiety, fertility, ovulation, sex hormones, psychologicalmood, sleep patterns, hunger & thirst, hormone type and concentration,cholesterol, lipids, blood panel, bone density, body fat density, muscledensity, organ and body weight, reflex response, sexual arousal, mentaland physical alertness, sleepiness, auscultatory information, responseto external stimuli, swallowing volume, swallowing rate, sickness, voicecharacteristics, tone, pitch, and volume of the voice, vital signs, headtilt, allergic reactions, inflammation response, auto-immune response,mutagenic response, DNA, proteins, protein levels in the blood, bodyhydration, water content of the blood, pheromones, internal body sounds,digestive system functioning, cellular regeneration response, healingresponse, stem cell regeneration response, and the like. Vital signs caninclude pulse rate, breathing rate, blood pressure, pulse signature,body temperature, hydration level, skin temperature, and the like. Aphysiological sensor may include an impedance plethysmograph formeasuring changes in volume within an organ or body (usually resultingfrom fluctuations in the amount of blood or air it contains). Forexample, the earpiece module 100 may include an impedance plethysmographto monitor blood pressure in real-time.

An external energy sensor 102, serving primarily as an environmentalsensor, can be any compact sensor for monitoring the externalenvironment in the vicinity of the body, such as, but not limited to,sensors for monitoring: climate, humidity, temperature, pressure,barometric pressure, pollution, automobile exhaust, soot density,airborne particle density, airborne particle size, airborne particleshape, airborne particle identity, volatile organic chemicals (VOCs),hydrocarbons, polycyclic aromatic hydrocarbons (PAHs), carcinogens,toxins, electromagnetic energy (optical radiation, X-rays, gamma rays,microwave radiation, terahertz radiation, ultraviolet radiation,infrared radiation, radio waves, and the like), EMF energy, atomicenergy (alpha particles, beta-particles, gamma rays, and the like),gravity, light properties (such as intensity, frequency, flicker, andphase), ozone, carbon monoxide, greenhouse gases, CO₂, nitrous oxide,sulfides, airborne pollution, foreign material in the air, biologicalparticles (viruses, bacteria, and toxins), signatures from chemicalweapons, wind, air turbulence, sound and acoustical energy (both humanaudible and inaudible), ultrasonic energy, noise pollution, humanvoices, animal sounds, diseases expelled from others, the exhaled breathand breath constituents of others, toxins from others, bacteria &viruses from others, pheromones from others, industrial andtransportation sounds, allergens, animal hair, pollen, exhaust fromengines, vapors & fumes, fuel, signatures for mineral deposits or oildeposits, snow, rain, thermal energy, hot surfaces, hot gases, solarenergy, hail, ice, vibrations, traffic, the number of people in avicinity of the user, the number of people encountered throughout theday, other earpiece module users in the vicinity of the earpiece moduleuser, coughing and sneezing sounds from people in the vicinity of theuser, loudness and pitch from those speaking in the vicinity of theuser, and the like.

In some embodiments, a physiological sensor 101 and/or an environmentalsensor 102 may be configured to identify a person to whom the earpiecemodule 100 is attached.

In some embodiments, a physiological sensor 101 and/or an environmentalsensor 102 may be configured to monitor physical aging rate of a personor subject. The signal processor 103 may be configured to processesinformation from a physiological sensor and/or an environmental sensorto assess aging rate. Physiological sensors configured to assess agingrate may include pulse rate sensors, blood pressure sensors, activitysensors, and psychosocial stress sensors. Environmental sensorsconfigured to assess aging rate may include UV sensors and pollutionsensors.

In some embodiments, a physiological sensor 101 and/or an environmentalsensor 102 may be configured to be regenerated through a physical and/orchemical change. For example, it is anticipated that an earpiece module100, or other device incorporating physiological and/or environmentalsensors according to embodiments of the present invention may be coupledto an apparatus that is configured to “recharge” or regenerate one ormore environmental and/or physiological sensors via a physical processor a chemical process, etc.

Because the earpiece module is capable of measuring and transmittingsensor information in real-time over a duration of time, thephysiological and environmental sensors 101, 102 can be used to sensethe aforementioned parameters over time, enabling a time-dependentanalysis of the user's health and environment as well as enabling acomparison between the user's health and environment. Combined withproximity or location detection, this allows an analysis for pinpointingthe location where environmental stress and physical strain took place.The signal processor 103 provides a means of converting the digital oranalog signals from the sensors 101, 102 into data that can betransmitted wirelessly by the transmitter 104. The signal processor 103may be composed of, for example, signal conditioners, amplifiers,filters, digital-to-analog and analog-to-digital converters, digitalencoders, modulators, mixers, multiplexers, transistors, variousswitches, microprocessors, or the like. For personal communication, thesignal processor 103 processes signals received by the receiver 104 intosignals that can be heard or viewed by the user. The received signalsmay also contain protocol information for linking various telemetricmodules together, and this protocol information can also be processed bythe signal processor 103. The signal processor 103 may utilize one ormore “compression/decompression algorithms used in digital media”(CODECs) for processing data. The transmitter 104 can be comprised of avariety of compact electromagnetic transmitters. A standard compactantenna is used in the standard Bluetooth headset protocol, but any kindof electromagnetic antenna suitable for transmitting at human-safeelectromagnetic frequencies may be utilized. The receiver 104 can alsobe an antenna. In some embodiments, the receiving antenna and thetransmitting antenna are physically the same. The receiver/transmitter104 can be, for example, a non-line-of-sight (N LOS) optical scattertransmission system. These systems typically use short-wave (blue or UV)optical radiation or “solar blind” (deep-UV) radiation in order topromote optical scatter, but IR wavelengths can also suffice.Additionally, a sonic or ultrasonic transmitter can be used as thereceiver/transmitter 104 of the earpiece module 100, but preferablyusing sounds that are higher or lower than the human hearing range. Avariety of sonic and ultrasonic receivers and transmitters are availablein the marketplace and may be utilized in accordance with embodiments ofthe present invention. If a telecommunication device 210 (FIG. 2)receiving wireless data signal 109 from the earpiece module 100 is inclose proximity to the earpiece module, a variety of transmissionschemes can be used. For communicating audible conversationalinformation directly to the earpiece user, encoded telemetricconversational data received by the receiver 104 can be decoded by thesignal processing module 103 to generate an electrical signal that canbe converted into audible sound by the communication module 107.

In some embodiments, the transmitter/receiver 104 is configured totransmit signals from the signal processor to the remote terminalfollowing a predetermined time interval. For example, the transmittermay delay transmission until a certain amount of detection time haselapsed, until a certain amount of processing time has elapsed, etc.

The power source can be any portable power source 106 capable of fittinginside the earpiece module housing. According to some embodiments, thepower source 106 is a portable rechargeable lithium-polymer or zinc-airbattery. Additionally, portable energy-harvesting power sources can beintegrated into the earpiece module 100 and can serve as a primary orsecondary power source. For example, a solar cell module can beintegrated into the earpiece module 100 for collecting and storing solarenergy. Additionally, piezoelectric devices or microelectromechanicalsystems (MEMS) can be used to collect and store energy from bodymovements, electromagnetic energy, and other forms of energy in theenvironment or from the user himself. A thermoelectric or thermovoltaicdevice can be used to supply some degree of power from thermal energy ortemperature gradients. In some embodiments, a cranking or windingmechanism can be used to store mechanical energy for electricalconversion or to convert mechanical energy into electrical energy thatcan be used immediately or stored for later.

The various components describe above are configured to fit within theearpiece housing 108 and/or be attached thereto. The earpiece modulehousing 108 may be formed from any safe and comfortable solid material,such as metal, rubber, wood, polymers, ceramic, organic materials, orvarious forms of plastic. The earpiece attachment component 105 isattached to the earpiece module housing 108 and is designed to fitaround or near the ear. For example, the standard Bluetooth headsetincludes an earpiece attachment that is connected to the headset housingvia a double-jointed socket, to provide comfort and positioningflexibility for the user. In some embodiments, the earpiece attachmentcomponent 105 can be part of the housing 108, such that the entireearpiece module is one largely inflexible, rigid unit. In such case, acounterweight may be incorporated into the earpiece module 100 tobalance the weight of the earpiece electronics and power source. In someembodiments, the earpiece attachment component 105 can containphysiological and environmental sensors, and the earpiece attachmentcomponent 105 may be detachable. In some embodiments, more than oneearpiece attachment 105 can be attached to the earpiece module housing108.

The communication and entertainment module 107 (also interchangeablyreferred to as a “communication module”) is used for, but not limitedto: processing or generating an audible sound from information receivedvia the receiver 104 (from a cell phone, computer, network, database, orthe like) and/or processing or generating an electrical signal from anaudible sound from the user such that the electrical signal can betransmitted telemetrically via the transmitter 104. For example, instandard Bluetooth protocol, communication electronics are used toconvert an audible conversation into an electrical signal for telemetricconversation; communication electronics are also used to convert adigitized telemetric conversation into an audible conversation for theearpiece user. Additionally, the communication and entertainment module107 can be used to store, process, or play analog or digital informationfrom music, radio shows, videos, or other audible entertainment and tocommunicate this information to an earpiece user. In many cases, thisinformation includes information received by the receiver 104. In manycases, the analog or digital information is not stored in thecommunication and entertainment module 107 but, rather, is stored in aportable telecommunication device 210 (FIG. 2). In such case, thecommunication and entertainment module 107 is used for converting theanalog or digital information into audible sound for the earpiece user.The communication and entertainment module 107 may contain at least onemicrophone, speaker, signal processor (similar to 103), and digitalmemory. In some embodiments, the communication and entertainment module107 may apply at least one CODEC for encoding or decoding information.The communication and entertainment module may utilize non-audible formsof communication with the user, such as visual, physical, or mental(i.e., brainwaves or neural stimulation) communication with the user.

In some embodiments, an audible communicator is provided that isconfigured to communicate therapeutic sounds (e.g., music therapy, etc.)to the person in response to physiological or psychosocial stress. Theaudible communicator may be embodied in the communication andentertainment module 107 or may be a separate speaker. In someembodiments, light therapy may be provided to the person in response tophysiological or psychosocial stress. In some embodiments, thecommunication and entertainment module 107 may be configured tocommunicate a treatment, therapy, and/or plan of action to the personupon detection of physiological and/or environmental concerns. Forexample, if it is detected that the person is being exposed to unhealthydoses of UV radiation, the communication and entertainment module 107may audibly instruct the person to move away from the person's currentlocation (e.g., move indoors, etc.).

Like the other components of the earpiece module 100 shown in FIG. 1,the components of the communication and entertainment module 107 are notnecessarily located in the same physical vicinity. The microphone andspeaker of the communication module 107, for example, are located closerto the mouth and ear respectively. Furthermore, the signal processor 103can be composed of several components located throughout the earpiecemodule. It should be understood that the word “module” does notnecessarily imply a unified physical location. Rather, “module” is usedto imply a unified function.

Bluetooth devices conventionally contain a communication module, such ascommunication module 107, for converting digital or analog informationinto audible sounds for the user. However, when combined with the healthand environmental monitoring properties of an earpiece module 100according to embodiments of the present invention, the communication andentertainment module 107 can provide functionality. For example, theearpiece module can serve as a biofeedback device. As a non-limitingexample, if a user is in a polluted environment, such as air filled withVOCs, the communication module 107 may notify the user to move to a newenvironment. As another example, if one or more of the physiological andenvironmental sensors 101, 102 of the earpiece module 100 pick up a highparticulate density in the environment, with an elevation in core bodytemperature, and a change in voice pitch occurring simultaneously (ornear-simultaneously) within a common timeframe, the communication module107 may alert the user that he/she may be having an allergic response.As a further example, the user can use the communication andentertainment module 107 to execute biofeedback for willfullycontrolling blood pressure, breathing rate, body temperature, pulserate, and the like. The communication module 107 may utilize audible orvisible alerts if the user is meeting their physiological targets orexceeding safe physiological limits. Alerting a user by physical orelectrical force, such as the sense of touch or tingling from anelectric pulse or vibration, can also be utilized. Thus, althoughcommunication by audible means is often utilized, the communicationmodule 107 can alert, signify, or communicate with the user throughsound, light, electrical actuation, and physical actuation.

As a second example of this biofeedback method, basic vital signscollected by the physiological sensors 101 and processed by the signalprocessor 103 can be presented to the earpiece user audibly, through thecommunication and entertainment module 107. For example, the user may beable to listen to his/her breathing rate, pulse rate, and the like.Additionally, an entertaining or aggravating sound or song can be usedto alert the user to favorable or unfavorable personal health andenvironmental factors occurring in real-time. This technique may beapplied towards education, such as positive or negative feedback foreducational games, learning games, or games of deception (e.g., poker,etc.).

In some embodiments, the earpiece module 100 may be configured todeliver and/or monitor drugs. For example, a transdermal drug deliverysystem may be provided that is controlled by earpiece electronics.Earpiece sensors can monitor the drug dosage and the physiologicaleffects of the drug in real-time.

A health and environmental network 200 according to embodiments of thepresent invention that may incorporate the earpiece module 100 of FIG. 1is illustrated in FIG. 2. The earpiece module 100 is a specific sensormodule 201 of the network 200, though other modules located at variousother parts of the body can be used in conjunction with, or in place of,the earpiece module 100. The terms “earpiece module 100” and “sensormodule 200” are used interchangeably herein in accordance with variousembodiments of the present invention. The health and environmentalnetwork 200 is composed of at least one sensor module 201 (e.g.,earpiece module 100) at least one portable telecommunication module 210,at least one transmission system 211, at least one user interface 214,at least one personal database 212, and at least one anonymous database213.

The sensor module 201 can be composed of a primary module alone or aprimary module and at least one secondary module. The secondary modulescan be located at any location of the body, but are preferably locatedin a region near the ear, and preferably the earpiece module 100 servesas the primary module. In most cases, the secondary modules are notnecessary. But in some cases, secondary modules may be located, forexample, behind the ear (near the lymph nodes), at or near the earlobes(such as one or more earrings or ear clips), at the front of the ear(near the carotid artery), at the temples, along the neck, or otherlocations near the ear. These wearable secondary modules can beconnected with either a “hard” connection to the primary module (such asan electric cable) or a “soft” connection to the primary module (such asa wireless connection). In Bluetooth protocol, each secondary module canbe simultaneously in direct wireless communication with the primarymodule. Primary modules and secondary modules in the same location canpromote quick-donning, ease-of-use, and comfortability for the end user.Users are not prone to accept multiple modules at multiple locations ofthe body.

The earpiece sensor module 201 communicates wirelessly with the portabletelecommunication device 210, preferably in an open architectureconfiguration, such as Bluetooth or ZigBee. The telecommunication device210 can be any portable device, such as a cell phone, PDA, laptopcomputer, Blackberry, another earpiece, or other portable, telemetricdevice. The portable telecommunication device 210 and the earpiecemodule 201 can telemetrically communicate both to and from each other.Though the main purpose of the portable telecommunication device is totransmit the local wireless signal from the sensor module 101 overlonger distances unattainable by the transmitter 104 of the sensormodule 201, the telecommunication 210 can also serve as a method ofpersonal communication and entertainment for the earpiece user.

In some embodiments, the telecommunication device 210 transmits data inonly one direction or particular directions. For example, in oneembodiment, the portable telecommunication device 210 can receivetelemetric information from the sensor module 201 but cannot send outsignals to a transmission system 211. The portable telecommunicationdevice 210 may also contain an end-user graphical interface, such as auser interface 214 in the network 200, such that data from the earpiecemodule 201 can be stored, analyzed, summarized, and displayed on theportable telecommunication device 210. For example, charts relatinghealth and environment, as well as real-time biofeedback and the like,can be displayed on a cell phone, media player, PDA, laptop, or otherdevice. The telecommunication device 210 may also contain physiologicaland environmental sensors itself, such as blood pressure, pulse rate,and pulse-oximetry, and the like. Additionally, the telecommunicationdevice 210 can communicate with the earpiece module 201 to transfercommands, activate or deactivate sensors, communicate with the user, andthe like.

The portable telecommunication device 210 sends/receives wirelessinformation directly to/from a transmission system 211 for transmissionto a database (such as personal database 312 and/or anonymous database313) for storage, analysis, and retrieval of data. The style oftransmission system depends largely on the location of the database. Forexample, if the database is located in a local computer, the wirelessinformation from the telecommunication device 210 can be sent directlyto the local computer. This computer may be connected with the Internet,allowing access to the database from the web. However, the database ismore typically located far away from the user and telecommunicationmodule. In this case, the wireless signal from the telecommunicationdevice 210 can be sent to a reception tower and routed through a basestation. This information can then be sent to a database through theInternet. A variety of other transmission protocols can be applied forconnection between the telecommunication device 210 and the databases212, 213.

The personal and anonymous databases 212, 213 represent databases thatmay or may not be located on the same computer. A key difference betweenthese two databases is not the physical location of the database butrather the type of information available on each database. For example,the anonymous database 213, containing health and environmental datafrom multiple indistinct earpiece users, can be public and accessiblethrough the Internet by various users. In contrast, the personaldatabase 212 contains health and environmental data that is personalizedfor each user, including personalized information such as name, birthdate, address, and the like. Users can log-in to their personalizedinformation in the personal database 212 through an interactive userinterface 214 and compare this information with information frommultiple users in the anonymous database 213 via a graphical userinterface.

The user interface 214 can be a computer monitor, a cell phone monitor,a PDA monitor, a television, a projection monitor, a visual monitor onthe earpiece module 201, or any method of visual display. (Audiblemethods and audio-visual methods can also be used for the user interface214.) For example, the user may log-in to their personal database 212through a computer user interface 214 and compare real-time personalhealth and environmental exposure data with that of other users on thenetwork 200. In some cases, the data from other users may be anonymousstatistics. In some cases, one or more users may have agreements to viewthe data of one or more other users, and in other cases, users may agreeto share mutual personalized data through the Internet.

A specific embodiment of a graphical user interface 300 is presented inFIG. 3. FIG. 3 shows an example of how a computer monitor may appear toa user logging-in to their personal database 212 and comparing their ownpersonal data with that of anonymous users in the same network 200. Inthis case, data from anonymous users is averaged into certaindemographics; the choice of the demographics to be displayed can beselected by the user accessing the personalized database. In thegraphical user interface 300 of FIG. 3, the user's personalized data,signified by a star, is compared with statistics from other users in ananonymous database 213. This allows the user to compare his/her healthand environment with that of others in selected demographics. Thus, thisnetwork 200 serves not only as a source of useful information from amedical standpoint, but also as a form of entertainment for curioususers.

The network 200 can be used in medicine for a variety of importantfunctions. As one example, a doctor can monitor the health of patientsthrough each patient's personalized database 212. If the earpiece module201 contains a dosimeter, the doctor can even monitor the efficacy ofprescribed medications, and the physiological response to medications,over time. This dosimetry approach is directly applicable to clinicalstudies of various treatments. For example, during a clinical trial, theearpiece module 201 can collect environmental data, drug dosimetry data,and physiological data from the earpiece user such that researchers canunderstand the etymology between drugs, genes, physiology, environment,and personal health.

Because of the high compliance of the earpiece module 100, primarily dueto the dual-modality as a health/environmental monitor and a personalcommunication/entertainment device, users are prone to wear this devicethroughout clinical trials, providing more valuable information for drugdiscovery and the pharmaceuticals market.

As a further example, the health and environmental network 200 can beused by dieticians to track the caloric intake, health, and physicalactivity of dieters. Similarly, the network 200 can be used by athletictrainers to monitor the diet, physical activity, health, and environmentof athletes. In many cases professionals are not necessary, and the usercan monitor his/her own diet, activity, athletic performance, etc.through the network without professionals, parents, guardians, orfriends monitoring their personal statistics.

In a specific example of the network 200, an earpiece user is a testsubject in a clinical trial for a new treatment, such as a new drug,physical therapy, medical device, or the like. The earpiece user'shealth and environment are monitored in real-time, and this data isstored on the earpiece module 201, the portable telecommunication device210, the personal database 212, or the anonymous database 213. Byaccessing the stored data, researchers managing the clinical trial canthen compare the statistics from multiple users to make correlationsbetween user environment, health, and the effectiveness of treatment.

It should be noted that algorithms for processing personal health andenvironmental data, diagnosing medical conditions, assessing healthstates, and the like do not need to be limited to the illustratednetwork 200. Various algorithms can also be integrated into the earpiecemodule 201 or telecommunication device 210 according to embodiments ofthe present invention. A data storage component in at least one of theseunits allows processed signal data to be stored, analyzed, andmanipulated to provide new knowledge to the user. This storage componentcan be any solid-state storage device, such as flash memory,random-access memory (RAM), magnetic storage, or the like. For example,the earpiece module 201 can be programmed to monitor certain habits,such as nail-biting. In this non-limiting example, the earpiece modulephysiological sensors 101 may monitor internal sounds, and an algorithmcan be implemented to monitor signatures of nail-biting sounds inreal-time. If the habit is identified by the algorithm, the earpiececommunication module 107 may instantly warn the user that the habit isoccurring. Alternatively, the algorithm may count the number of times aday the habit occurred, monitor physiological and psychological stressindicators during each occurrence, log each time when the habitoccurred, and store environmental data associated with the habit. Thisstored data can be accessed at a later time, allowing the user todetermine what environmental factors cause the physiological orpsychological stress associated with nail-biting. As this example shows,these algorithms can take advantage of both physiological sensor 101data and environmental sensor 102 data.

A data storage component may include various algorithms, withoutlimitation. In some embodiments, at least one algorithm is configured tofocus processing resources on the extraction of physiological and/orenvironmental information from the various environmental and/orphysiological sensors. Algorithms may be modified and/or uploadedwirelessly via a transmitter (e.g., receiver/transmitter 104 of theearpiece module 100)

The biofeedback functionality of the telemetric earpiece module 100 canbe applied towards various gaming applications. For example, one or moreearpiece users can connect their earpiece modules 100 to one or moregaming devices wirelessly through the open architecture network providedby Bluetooth, ZigBee, or other such networks. This allows personalhealth and environmental information to be transferred wirelesslybetween the earpiece module 100 and a gaming device. As earpiece usersplay a game, various personal health and environmental feedback can bean active component of the game. In a non-limiting embodiment, two usersplaying a dancing game, such as Dance Dance Revolution, can monitortheir vital signs while competing in a dancing competition. In somecases, users having healthier vital signs, showing improved athleticperformance, will get extra points (“Vital Points”). In another specificexample, this personal health and environmental information can be senttelemetrically to a gaming device to make entertaining predictions aboutone or more users. Namely, the gaming device may predict someone's lifeexpectancy, love-life, future occupation, capacity for wealth, and thelike. These predictions can be true predictions, purely entertainingpredictions, or a mixture of both. Sensors measuring external stressors(such as outside noise, lighting conditions, ozone levels, etc.) andsensors measuring internal stresses (such as muscle tension, breathingrate, pulse rate, etc.) integrated into the earpiece module 100 can beused to facilitate predictions by the gaming device. For example, theinformation from the sensors can be recorded from one or more earpieceusers during a series of questions or tasks, and the information can besent telemetrically to a gaming device. An algorithm processed in thegaming device can then generate an entertaining assessment from theinformation. This game can be in the form of a video game, with agraphical user interface 214, or it can be a game “in person” through anentertainer. Other games can involve competitions between multipleearpiece monitor users for health-related purposes, such as onlinedieting competitions, fitness competitions, activity competitions, orthe like. Combining the telemetric earpiece module 100 with gaming,according to embodiments of the present invention, provides seamlessinteraction between health and environmental monitoring and the game,through a comfortable telemetric module. Other sensor modules 201located at other parts of the body can also be used.

An additional non-limiting embodiment of the biofeedback functionalityof the earpiece module 201 can be monitoring psychological andphysiological stress (such as monitoring stress indicators) during apoker game. These stress indicators can be breathing rate, muscletension, neurological activity, brain wave intensity and activity, corebody temperature, pulse rate, blood pressure, galvanometric response,and the like. Users may, for example, use the earpiece module 201 torecord or display their psychological and physiological stress during apoker game in real-time. This information can be stored or displayed ona portable telecommunication device 210 or sent wirelessly to otherparts of the network 200. The user can use this biofeedback to adjusttheir psychological and physiological stress (or stress indicators)through force of will. This biofeedback process allows earpiece users toself-train themselves to project a certain “poker face,” such as a stoiccold look, a calm cool look, or another preferred look. Additionally,external stressors, such as light intensity and color, external sounds,and ambient temperature, can be sensed, digitized, and transmitted bythe earpiece module 100 to a telecommunication device (for storage),providing the user with important information about how the externalenvironment may be affecting their stress response and, hence, pokergame. In some games, the stress indicators may be displayed for outsideviewers (who are not part of the poker game) as a form of entertainmentwhen watching a group of poker players (each having earpiece modules201) in a casino, television, or through the Internet.

The biofeedback approach is also directly relevant to personal educationas a learning tool. For example, monitoring the physiological andpsychological response to learning can be used to help users understandif they are learning efficiently. For example, in the course of reading,the earpiece module 201 can monitor alertness through galvanometric,brainwave, or vital sign monitoring. The user can then use thisinformation to understand what reading methods or materials arestimulating and which are not stimulating to the earpiece user.

In the broader sense, the discussed earpiece-enabled biofeedback methodcan be used as a self-training tool for improving performance in publicspeaking, athletic activity, teaching, and other personal andjob-related activities.

The health and environmental network 200 enables a variety of additionalbusiness methods. For example, users can be charged a fee fordownloading or viewing data from the personal and/or anonymous databases212, 213. Alternatively, users may be allowed free access but berequired to register online, providing personal information with norestrictions on use, for the right to view information from thedatabases. In turn, this personal information can be traded or sold bythe database owner(s). This information can provide valuable marketinginformation for various companies and government interests. The healthand environmental data from the databases 212, 213 can be of great valueitself, and this data can be traded or sold to others, such as marketinggroups, manufacturers, service providers, government organizations, andthe like. The web-page or web-pages associated with the personal andanonymous databases 212, 213 may be subject to targeted advertising. Forexample, if a user shows a pattern of high blood pressure on a personaldatabase 212, a company may target blood pressure treatmentadvertisements on the user interface 214 (i.e. web page) while the useris logged-in to the personal database through the user interface 214.For example, because various health and environmental statistics ofearpiece users will be available on the database, this information canbe used to provide a targeted advertising platform for variousmanufacturers. In this case, a database manager can sell information toothers for targeted advertising linked to a user's personal statistics.In some cases, a database owner does not need to sell the statistics inorder to sell the targeted advertising medium. As a specific example, acompany can provide a database owner with statistics of interest fortargeted advertising. For example, the company may request advertising aweight-loss drug to anonymous users having a poor diet, high caloricintake, and/or increasing weight. A database manager can then charge thecompany a fee for distributing these advertisements to the targetedusers as they are logged-in to the database website(s). In this way, theusers remain anonymous to the company. Because targeted advertisementscan be such a lucrative market, income from these sources may eliminatethe need for charging users a fee for logging-in to the databases 212,213.

The earpiece module 201 and earpiece module network 200 can enable avariety of research techniques. For example, a plurality of earpiecemodules 100 worn by users can be used in marketing research to study thephysiological and psychological response of test subjects to variousmarketing techniques. This technique solves a major problem in marketingresearch: deciphering objective responses in the midst of humansubjectivity. This is because the physiological and psychologicalresponse of the earpiece user largely represents objective, unfilteredinformation. For example, users that are entertained by a pilot TVprogram would have difficulty hiding innate vital signs in response tothe program. The data generated by the earpiece module 201 during marketresearch can be transmitted through any component of the telemetricnetwork 200 and used by marketing researchers to improve a product,service, or method.

Another business method provided by the network 200 is to charge usersof the network for usage and service (such as compilation service). Forexample, a clinical trial company may pay a fee for accessing thedatabases 212, 213 of their test subjects during medical research. Inthis case, these companies may buy earpiece modules 201 and pay for theservice, or the earpiece modules 201 may be provided free to thesecompanies, as the database service can provide a suitable income itself.Similarly, doctors may pay for this service to monitor patients, firefighters and first responders may pay for this service to monitorpersonnel in hazardous environments, and athletic trainers may pay forthis service to monitor athletes. Also, users can pay for the databaseservice directly themselves. Because these databases 212, 213 aredynamic, updated regularly via the earpiece module 201 of each user, andchanging with time for individual users and users en mass, thesedatabases can maintain a long-term value. In other words, there mayalways be new information on the databases 212, 213.

Another embodiment of the present invention involves methods ofcombining information from various earpiece health sensors into ameaningful real-time personal health and environmental exposureassessment in a recording device. The meaningful assessment is generatedby algorithms that can be executed in the earpiece 201, in the portabletelecommunication device 210, or through various other electronicdevices and media within the network 200. In one embodiment, raw orpreprocessed data from the sensor module 201 is transmitted wirelesslyto the telecommunication device 210, and this device executes variousalgorithms to convert the raw sensor data (from one or more sensors)into a meaningful assessment for the user. In another embodiment thesealgorithms are executed within the earpiece 201 itself, without the needfor processing in the telecommunication device 210. The output fromthese algorithms can be viewed as charts, graphs, figures, photos, orother formats for the user to view and analyze. Preferably, theseformats display various health factors over time with respect to aparticular environment, with health factor intensity on the dependentaxis and time or environmental factor intensity on the independent axis.However, virtually any relationship between the physiological data andenvironmental data can be processed by the algorithm, and theserelationships can be quantitative, qualitative, or a combination ofboth.

One innovation involves applying the earpiece sensor module 201 towardsa physical or mental health assessment method. An algorithm may combinedata from health and environmental sensors 101, 102 towards generating apersonal overall health assessment for the user, conditional to aparticular environment. For example breathing rate, pulse rate, and corebody temperature can be compared with ozone density in the air forgenerating an ozone-dependent personal health assessment. In anotherspecific example of this innovation, information from the earpiecesensors 101, 102 can be used to monitor overall “mood” of a user in aparticular environment. More particularly, algorithmic processing andanalyzing of data from sensors for core body temperature, heart rate,physical activity, and lighting condition can provide a personalassessment of overal mood conditional on external lighting conditions.

As previously mentioned, the ear is located at an ideal physiologicalposition for monitoring a variety of health and environmental factors.Thus, the ear location can enable a variety of methodologies forphysiological and environmental monitoring with an earpiece module 100.In particular, because the ear canal is naturally designed for thetransmission of audible sound, the ear canal facilitates methods formonitoring physiological processes by monitoring internal sounds.However, when extracting physiological information from the body, in agiven external environment, environmental information is inevitably partof the extracted signal. This is because external energy, such asexternal audible noise, is entering the body. Thus, when listening tointernal sounds, external sounds are also picked up. A methodology forcleaning up the signal such that it contains clearer information aboutphysiology (as opposed to external environment) is provided by someembodiments of the present invention.

FIG. 4 illustrates a physiological signal extraction methodology 400 forselectively monitoring internal physiological energies through anearpiece module 420 according to embodiments of the present invention.In the illustrated method, internal physiological energy is sensed by asensor designated “Sensor-1” 401. Sensor-1 generates an electricalsignal in response to the physiological energy. One or more externalsensors 402, 403, and 404 sense external energy from the environment inthe vicinity of the earpiece module user and generate an electricalsignal in response to the external energy. Though only one externalsensor is needed, multiple sensors can be used to add sensingfunctionality, improve signal extraction, and/or increase theselectivity of sensing various energies. In FIG. 4, the external energysensors 402, 403, 404 are shown collecting energy from differentdirections to emphasize that each sensor can be sensing the same type ofenergy but from a different direction, as this directional informationcan be useful for various assessments of the earpiece user. The energiesdescribed can be any physical energy, such as electrical, magnetic,electromagnetic, atomic, gravity, mechanical, acoustic, and the like. Asignal processor 405 collects the electrical sensor responses andprocesses these signals into a signal that can be transmitted wirelesslythrough a transmitter/receiver 406 for communicating the information 407telemetrically between the earpiece module 420 and a portabletelecommunication device 210 (FIG. 2).

As with processor 103 of FIG. 1, the signal processor 405 of FIG. 4 canbe used to combine signals from the various sensors, comparesimilarities between the signals, and generate a new signal thatcontains cleaner physiological information than any of the originalsignals. This can be done by converting the analog signals from thephysiological sensors 401 and environmental sensors 402, 403, and 404into digital signals and comparing the signals in, for example, adigital comparator to form a new signal that contains cleanerphysiological information. (In some cases, an analog comparatortechnique can also be used if the signals are not digitized.) If thesedigitized signals are synchronized in time, a subtraction ofenvironmental features from the signals can be realized by thecomparator. Further, if algorithms are integrated into the signalprocessor 405, comparisons can be made with respect to how externalenergy affects physiological energy in time.

An embodiment of the physiological signal extraction methodology 400 ispresented in FIG. 5 as an acoustical-cancellation physiological signalextraction methodology 500. An earpiece module 517 (for example, withthe functionality of earpiece module 100 of FIG. 1) is attached to theear 506 with an ear attachment 505. This earpiece module 517 isphysically similar, if not identical, to the various examples shown inFIGS. 9-16, discussed below. The earpiece module 517 contains at leastone physiological acoustical sensor 501 pointed in the direction of thetympanic membrane 520 and at least one external acoustical sensor 502pointing away from the body and towards the outside environment. Tosuppress the convolution of external and internal sounds, an acousticalbuffer region 519 is placed between the two sensors 501, 502.Environmental sounds 507 are sampled by the external acoustical sensor502, and physiological sounds 508 traveling through the ear canal 530(and towards the earpiece 517) are sampled by the physiologicalacoustical sensor 501. Because the tympanic membrane and other bodyparts and tissues naturally vibrate in response to external sounds 507,part of the physiological acoustical energy 508 is composed ofenvironmental acoustical energy 507 as well as physiological sounds.These physiological sounds are referred to as “auscultatory”information. By comparing digitized signals from each acoustical sensor501, 502, the external energy 507 signatures can be at least partiallyremoved from the auscultatory 508 signatures such that a new signal,containing cleaner physiological information, can be generated. Forexample, the sounds of external steps and human voices can be digitallyremoved or reduced from the final processed signal such that the finalsignal contains a cleaner representation of the internal sounds of pulserate, breathing rate, swallowing rate, and other auscultatoryinformation.

The acoustical sensors 501, 502 can contain any acoustical transducer,such as a microphone, piezoelectric crystal, vibrating membrane,magnetic recorder, and the like. Further, the acoustical sensors 501,502 may contain a variety of layers for filtering sounds and promotingthe directional extraction of sound. Additionally, various electricalfilters, such as low-pass, high-pass, band-pass, notch, and otherfilters, can be used to clean-up signals from each sensor 501, 502 tohelp remove unwanted sounds or signatures. In some embodiments, theacoustical sensors 501, 502 are compact microphones, such as electricmicrophones or piezoelectric microphones, and the signals from thesemicrophones are electrically filtered. The acoustical buffer region 519can be any material that absorbs acoustical energy. In some embodiments,this material is soft, durable material, such as plastic, foam, polymer,or the like. In some embodiments, the acoustical buffer region 519 canbe specially shaped to reflect or absorb sounds of certain frequenciesthrough acoustical interference.

An example of how the auscultatory signal extraction technique 500 maybe used is summarized in test data 800 set forth in FIG. 8. A smallmicrophone was placed inside the ear of a test subject, and varioussounds were recorded over time. In the test data 800, the user wasrelaxing on a chair. The raw waveform 801 contains information frominternal and external sounds. However, following digital filtering andnoise cancellation, the final energy spectrum 802 and waveform 803contain cleaner information about the test subject's pulse rate. Infact, the signature of each pulse can even be identified. In processingthis signal, the noise reduction algorithm was selected by intelligentlychoosing a data segment dominated by external (environmental) acousticalenergy, where physiological information was largely not present. Suchintelligent algorithms can be integrated into a Bluetooth earpiecemodule for automatic auscultatory analysis for extracting physiologicalsounds from the body. Because the nature of external sounds and internalsounds are known by the placement of sensors 501, 502, providing a basisfor signal subtraction, the acoustical signal extraction innovation 500can provide clean auscultatory data automatically in real-time.

Another embodiment of the signal extraction methodology 400 is presentedin FIG. 6. The optical physiological signal extraction technique 600 isa method of extracting a variety of physiological information form thetympanic membrane 620 by locking-in to the vibrational frequency of thetympanic membrane 620. In this method 600, the earpiece module 614contains at least one acoustical energy sensor 601 for measuringacoustical energy coming from the ear canal 630 and other neighboringorgans and tissues. At least one optional external acoustical energysensor 602 can be used for measuring environmental sounds in thevicinity of the earpiece user, as the combined signals from sensors 601,602 can produce a cleaner signal for physiological monitoring. At leastone optical emitter 624 is located in the earpiece for generatingoptical energy directed towards the tympanic membrane 620 through theear canal 630. This optical energy is absorbed, scattered, and reflectedby the ear canal 630 and tympanic membrane 620. In some cases, theoptical energy induces fluorescence in the ear canal or tympanicmembrane. In other cases, the optical energy experiences a change inpolarization or other optical properties. In many cases, a change inmore than one optical property (absorption, reflection, diffraction,fluorescence, polarization, etc.) occurs. In any case, this resultingoptical energy is referred to as the “secondary energy.” The secondaryenergy is detected by at least one optical detector 625, though morethan one optical detector 625 may be utilized. As with the acousticalsensors 601, 602, the optical detector 625 converts incoming energy (inthis case optical energy) into an electrical signal to be sent to asignal processor 405 (FIG. 4). The optical detector 625 may containfilters for selectively passing optical energy of physiologicalinterest. A buffer region 619 is used to prevent external sound andlight from convoluting the extraction of physiological information. Inmany cases, the optical energy generates a secondary response that isnot optical in origin, such as a thermal response or biochemicalresponse. In such case, at least one optical detector 625 may bereplaced with at least one other type of sensor for sensing thenon-optical secondary response.

Because the thin tympanic membrane 620 vibrates significantly inresponse to sound, whereas the other physiological ear features, such asthe ear canal 630 and external ear 606 do not vibrate significantly, amethod of extracting secondary optical signals scattered from thevibrating tympanic membrane 620 is provided. Acoustical information fromthe tympanic membrane vibrational response, collected by the acousticalsensor 601 (or a combination of sensors 601, 602), is processed by asignal processor 405, and the secondary optical information from thetympanic membrane is collected by the optical detector(s) 625. Thesignal processor compares digitized signals from these sensors insynchronized time, such that signals from the optical detector 625containing frequency components characteristic of the tympanicmembrane's vibrational response are selectively extracted to providecleaner physiological information from the tympanic membrane. Forexample, the oxygen content of blood in the tympanic membrane can bemonitored by the reflection of red and infrared light from the tympanicmembrane, similar to pulse-oximetry. However, scattered optical energyfrom the ear canal may make it difficult to extract blood oxygen fromthe tympanic membrane, as the source of scattered light is unclear. Theoptical physiological signal extraction methodology 600 provides a meansof locking-in to the tympanic membrane optical reflection signal throughthe tympanic membrane vibrational signal collected by the acousticalsensor 601 (or the combination of sensors 601, 602). The illustratedmethodology 600 works because the thin tympanic membrane 620, inresponse to sound, vibrates with substantially greater deflection thanthe ear canal, and thus primary and secondary light scattered from thetympanic membrane 620 is largely modulated by the frequency of soundreaching the tympanic membrane. This same technique 600 can be appliedtowards monitoring scattered optical energy from the vibrating bones ofthe ear, using electromagnetic wavelengths capable of passing throughthe tympanic membrane.

Another non-limiting embodiment of the optical physiological signalextraction methodology 600 of the present invention involves dosimetry.For example, the concentration of a drug and/or the performance of adrug can be monitored over time by characterizing the real-timefluorescence response of the drug, or intentional fluophores placed inthe drug, via the tympanic membrane. In such case, the fluorescenceresponse of the tympanic membrane can be extracted from optical noisethrough the illustrated methodology 600. However, in this case thefluorescence response, as opposed to the reflectance response, isextracted from the tympanic membrane 620.

In the optical physiological signal extraction methodology 600, avariety of devices can be used for the optical source or optical sources624, such as a light-emitting diode (LED), a laser diode (LD), aminiature lamp (such as a miniature incandescent lamp, a miniaturemercury lamp, or a miniature tungsten lamp), a light guide deliveringlight from an outside source (such as the sun or other light source), amulti-wavelength source, a microplasma source, an arc source, acombination of these sources, and the like. Special variants oflight-emitting diodes, such as resonant-cavity light emitting diodes(RCLEDs), superluminescent LEDs (SLEDs), organic LEDs (OLEDs), and thelike can also be applied.

In some embodiments of FIG. 6, coherent light can be used to monitorphysiological processes. Monitoring vibrating membranes can beaccomplished by using lasers and LDs such that coherent optical energycan directly interrogate the membrane and interference signals can beextracted. However, the signal extraction approach of FIG. 6 allowsphysiological signal extraction from the tympanic membrane withincoherent light-emitting diodes, which use less power, are morecommercially available, and are more cost-effective than laser diodes.In fact, the scattered light from LEDs can be an advantage as scatteredlight may be necessary for reaching the tympanic membrane from outsideof the ear canal. More specifically, earpiece module users may prefer tonot have a tube stuck deep into the ear canal, and thus there may be nodirect, unobstructed optical path to the tympanic membrane from outsideof the ear.

It should be noted that in some cases the optical physiological signalextraction methodology 600 can be implemented without the opticalemitter 624. For example, the native IR blackbody radiation of thetympanic membrane, scattered in proportion to acoustical vibrationalmotion of the tympanic membrane, can be extracted using the approach 600of FIG. 6 without the need of an optical emitter 624. This may beaccomplished by locking-in to the acoustically modulated blackbody IRradiation from the tympanic membrane, sensed by the photodetector 625,through the signals received by the acoustic sensor 601 or 602. Theextracted blackbody radiation from the tympanic membrane can then beprocessed by a signal processor 103 to yield a resulting signalindicative of core body temperature. In this embodiment, thephotodetector 625 may be, for example, an IR sensor, an IR photodiode,an IR avalanche photodiode, an IR photoconductor, an IR-detectingfield-effect transistor, a fast-response thermal sensor such as apyroelectric sensor, or the like.

A specific pictorial example of the innovative optical physiologicalsignal extraction methodology 600, incorporating an LED-photodetectormodule 700, is shown in FIG. 7. In the illustrated module 700, at leastone LED 724 generates at least one optical beam 713 directed towards thetympanic membrane 720 through the ear canal 730. At least onephotodetector 725 is positioned to receive scattered light 717 modulatedby the tympanic membrane 720. Inevitably, scattered light from the earcanal 730 not associated with the tympanic membrane will also reach thephotodetector 725. The optical physiological signal extractionmethodology 600, according to some embodiments of the present invention,can be used to reduce the impact of scattered light from the ear canal730 and increase the impact of scattered light from the tympanicmembrane 720.

An optical reflector 727 may be used to steer the light from the LED 724towards the tympanic membrane 720 and away from the photodetector 725,preventing convolution and saturation by the optical source light 713.The LED 724 and photodetector 725 are mounted onto a mounting board 726in a discrete module, and this discrete module may be mounted to alarger board 710 for integration with circuitry in an earpiece sensormodule 100. Mounting of components to the board 726 and the board 726 tothe larger board 710 can be accomplished, for example, by heatingsoldering bumps underneath the parts through standard electronicsoldering techniques. The photodetector 724 can be any solid statedevice, such as a photodiode, an avalanche photodiode, a photoconductor,a photovoltaic, a photomultiplier, a FET photodetector, aphotomultiplier tube, or the like. In some cases, the larger mountingboard 710 may be connected to a detachable element, such as a cable,jack, fixture, or the like.

The active optical absorption region of the photodetector 725 may becovered by at least one optical filter for selectively passing light ofinterest. Light-guiding optics may also be integrated. Optical filtersand light-guiding optics may also be applied to the LED source 724. TheLED 724 can be any optical wavelength from the deep-UV to the deep-IR.In some cases, the LED 724 can be replaced with a laser diode or othercompact laser source, as long as electrical powering requirements aresatisfied. In such case, the laser diode may need to be pulsed on a setinterval to prevent a battery drain from continuous laser diode usage.

Referring back to FIG. 4, the directional external energy sensors 402,403, and 404 can be useful for monitoring multiple sounds at once anddeconvoluting interference from other sounds. For example, to monitorfoot-steps (pedometry), physical activity, and/or the impact on vitalsigns, signals from the sensors 401, 402, 403, and 404 can all beprocessed together, via the signal processor 405, to generate meaningfulinformation about each factor. More specifically, the sound of footstepscan be extracted from the final processed signal by deconvolutingdirectional sounds from above the earpiece user, through Sensor-3 403,and by deconvoluting directional sounds from the side of the earpieceuser, through Sensor-2 402. In this manner, sounds from footsteps,coming primarily from below the user, measured through Sensor-4 404, andfrom inside the user, measured through Sensor-1 401, can be extractedfrom interfering sounds coming from other, non-relevant directions.

According to some embodiments of the present invention, a person'svitals signs can be extracted through the same methodology, but in thiscase, the sounds measured from at least one external energy sensor(Sensor-2, Sensor-3, or Sensor-4 404) are also deconvoluted from thefinal signal such that the final signal contains cleaner physiologicalinformation than that from Sensor-1 401 alone. As a further example ofthe acoustical signal extraction methodology 500 of the presentinvention, the signal extraction technique can be used to extractacoustical signals associated with one or more of the following:yawning, swallowing, eating, masticating, sleeping, slurping, walking,running, physical activity, jogging, jumping, teeth grinding, jawmovements, a change in bite, changes in speech, changes in voice(volume, pitch, speed, inflammation of vocal chords, etc.), coughing,snoring, sneezing, laughing, eye muscle movements, crying, yelling,vocal stress, physical and psychological stress, stuttering, digestion,organ functioning, vital signs, pulse rate, breathing rate,cardiovascular performance, pulmonary performance, lung capacity,breathing volume, blood pressure, athletic performance, physiological orpsychological stress indicators, the number of typed words on a keyboardor typing rate, personal habits (such as scratching, nail biting, saying“um,” hair pulling, smoking, and the like), emotional states, muscletension, and the like.

It should be clear that the general physiological signal extractionmethodology 500 is also applicable in the reverse. Namely, the externalenvironmental energy can be extracted from the convolution of externalenergy with physiological energy through the same basic process. In suchcase, the signal processor 405 subtracts signatures associated withinternal physiological energy such that the new processed signalcontains cleaner information about the environment. It should also beclear that any of the sensors 401, 402, 403, and 404 can be composed ofmultiple sensors measuring multiple forms and expressions of variousphysical energies.

The earpiece modules described herein need not be embodied withinheadsets. For example, an earpiece module 100 according to embodimentsof the present invention can be a hearing aid, an earplug, anentertaining speaker, the earpiece for an IPOD, Walkman, or otherentertainment unit, a commercial headset for a phone operator, anearring, a gaming interface, or the like. The earpiece module 100 coversthe broad realm of earpieces, ear jewelry, and ear apparatuses used bypersons for entertainment, hearing, or other purposes both inside andoutside of health and environmental monitoring.

Moreover, two earpiece modules 100 may be utilized, one for each ear ofa person, according to some embodiments of the present invention.Dual-ear analysis with two earpiece modules can be used, for example, tocompare the core temperature of each tympanic membrane in order to gaugebrain activity comparing each brain hemisphere. In another case,acoustical energy, including ultrasonic energy, can be passed from oneearpiece module to the other, with acoustic absorption and reflectionbeing used to gauge various physiological states. For example, thistechnique can be used to gauge hydration level in the head or brain byestimating the acoustical energy absorption rate and sound velocitythrough the head of the user.

A variety of earpiece styles, shapes, and architectures can be used forearpiece module 100 according to embodiments of the present invention. Anon-limiting embodiment of the earpiece module is shown pictorially inFIG. 9. The illustrated earpiece 905 fits over the ear of a person andis held in place by an ear support 901 (also called the “earpieceattachment component” 105). The illustrated earpiece module 905 alsoincludes an earpiece body 902, an earpiece fitting 908, and an optionalearlobe clip 904. The earpiece may also contain an adjustable mouthpiece1416 (FIG. 14B) and/or a pinna cover 1402 (FIGS. 14A-14B) describedbelow. The earpiece 905 connects with the ear canal of a person throughan earpiece fitting 908 located on the backside 906 of the earpiece 905.The earpiece fitting 908 transmits sound to the inner ear and eardrum.Health and environmental sensors are integrated primarily within oralong the earpiece body 902, including the earpiece backside 906.However, an earlobe clip 904 can contain various health andenvironmental sensors as well. In some cases, health and environmentalsensors can be integrated within or along the ear support 901, theadjustable mouthpiece 1416, the earpiece fitting 908, or the pinna cover1402. Raw or processed data 903 from these sensors can be wirelesslytransferred to a recording device or a portable telecommunication device210 (FIG. 2). In some embodiments of the present invention, a recordingdevice can be located within or about the earpiece 905 itself. In somecases, this recording device is flash memory or other digitized memorystorage. The types of health and environmental factors which may bemonitored have been previously described above for the earpiece module100.

It should be understood that the earpiece body 902 can be any shape andsize suitable for supporting an earpiece fitting 1008. In some cases,the earpiece body and earpiece fitting can be one and the samestructure, such that the earpiece body-fitting is a small fitting insidethe ear. In many cases, it is desirable to seal off or partially sealoff the ear canal so as to prevent sounds from entering or leaving theear such that auscultatory signal can more easily be extracted from theear canal through devices (such as microphones) in the earpiecebody-fitting.

It should be noted that the invention is not limited to the exemplaryearpiece 905 of FIG. 9. Other earpiece configurations are also capableof integrating health and environmental sensors for portable,noninvasive, real-time health monitoring according to embodiments of thepresent invention. For example, the earlobe clip 904 can be modified toreach other surfaces along or near a person's ear, head, neck, or faceto accommodate electrical or optical sensing. Similarly, more than oneclip may be integrated into the earpiece 905. Sensors can be integratedinto the earpiece-fitting 1008 as shown in the earpiece 1002 of FIG. 10.In such embodiments, the sensors may be integrated into a module 1009 inthe earpiece-fitting 1008. Environmental sensors are preferably locatedon the outside of the earpiece 1205 through a region on the earpiecefrontside 1206 (as shown in FIG. 12). This allows access to air in thevicinity of the earpiece user. However, environmental sensors can belocated anywhere along the earpiece module 905.

FIG. 12 illustrates details about the location of sensors in certainparts of an earpiece module 1205, according to embodiments of thepresent invention. The ear support 1201 contains a pinna cover 1202 thatmay contain sensors for monitoring physiological and environmentalfactors. This structure is particularly useful for sensing methodologieswhich require energy to be transmitted through the thin layers of thepinna (the outer ear). Though any portion of the pinna can be coveredand/or contacted, in some embodiments, the pinna cover 1202 overlaps atleast a part of the helix or a part of the scapha of an ear. Likewise,an optical absorption detector, composed of an optical emitter andoptical detector, can be integrated into the pinna cover 1202 formonitoring, for example, hydration, dosimetry, skin temperature,inductive galvanometry, conductive galvanometry, and the like.

Galvanometry, the measurement of electrical properties of the skin, canbe measured inductively, through contactless electromagnetic inductionwithout contacts, or conductively, with two, three, four, or moreconductivity probes. Additionally, a 4-point conductivity probetechnique, such as that used for measuring the conductivity ofsemiconductor wafers, can be applied. A variety of sensors can beintegrated into the earpiece fitting 1208. For example, a galvanometricdevice can be integrated into the surface 1209 of the earpiece fittingwhere the earpiece fitting touches the skin of the outer ear.Additionally, an inductive device, such as an inductive coil 1214, canbe integrated along the earpiece fitting body to measure movements ofthe tympanic membrane inductively. The inductive impedance can also bemeasured with the inductive coil 1214 or another inductive sensor, andthis can be applied towards contactless galvanometry. The inductive coil1214 can include one or more coils arranged in any orientation, and acore material, such as an iron-containing material, may be used toimprove the sensitivity of the response. In some cases, multiple coilsmay be used to facilitate the canceling of stray electromagneticinterference. Sensors can also be integrated into the end tip 1212 ofthe earpiece fitting 1208 to measure physiological properties deeperinto the ear canal. For example, the optical module 700 of FIG. 7 may belocated in, at, or near the end tip region 1212 in a module 1213. Thesensors on the module 1213 in this region are carefully arranged so asnot to prevent the transmission of sound (from the built-incommunication module 107) and to not be distorted during earpieceplacement and removal. The end tip sensor module 1213 can containseveral types of sensors for generating multiple types of energy anddetecting multiple types of energy, and this module can be integratedinto the speaker module (part of the communication module 107) insidethe earpiece fitting 1208 that is used for sound transmission to theuser during telemetric conversations. In some cases, the speaker modulecan be used as a microphone to measure auscultatory signals from thebody. This may be especially useful for measuring low frequency signalsless than 1000 Hz. Employing the speaker as a microphone may requireimpedance matching to maximize the auscultatory signal extraction.

Alignment, placement, and arrangement of sensors, according toembodiments of the present invention, can be enabled or simplified byadopting a flexible circuitry configuration 1300, such as that shown inFIG. 13. A flexible circuit board 1304 according to embodiments of thepresent invention can be made out of any stable flexible material, suchas kapton, polymers, flexible ceramics, flexible glasses, rubber, andthe like. A key requirement of the flexible material of the flexiblecircuit board 1304 is that it must be sufficiently electricallyinsulating and electrochemically inert. As with a standard rigid circuitboard, a variety of sensors 1306 can be mounted on the flexible circuitboard 1304, and this board can be integrated into any part of theearpiece module 905 (FIG. 9). Flexible circuitry can be especiallyuseful for odd-shaped components of the earpiece, such as the earpiecefitting 908, ear support 901, the earpiece clip 904, the adjustablemouthpiece 1416, and the pinna cover 1202/1402. In some cases, flexiblepiezoelectric polymers, such as polyvinylidene fluoride may be usefulfor measuring body motion and auscultatory sounds from the body.

FIGS. 14A-14B illustrate an embodiment 1400 of an earpiece module 1405with an adjustable mouthpiece 1416 and a pinna cover 1402. The earpiece1400 contains a region where an adjustable mouthpiece 1416 can beswiveled, extended, pulled, extracted, flipped, or ejected towards themouth. A microphone at the end of the mouthpiece 1416 can be used toimprove personal communication through the earpiece 1400. Sensorsintegrated into the mouthpiece 1416 can be used to monitor, for example,exhaled breath for respirometry and inhalation/exhalation monitoring.Carbon dioxide, oxygen, nitrogen, water vapor, and other respired gasesand vapors can be monitored, providing an overall assessment of health.Additionally, VOC's and other vapors exhaled by the breath can bemonitored for diagnosing various disease states, such as diabetes,obesity, diet, metabolism, cancer, hepatic or renal health, organfunctioning, alcoholism, halitosis, drug addiction, lung inflammation,voice analysis, voice distinction, and the like. The mouthpiece 1416 isin a retracted or stored position in FIG. 14A and is in an extended oroperative position in FIG. 14B.

Another multifunctional earpiece module 1500, according to embodimentsof the present invention, is illustrated in FIG. 15. The illustratedearpiece module 1500 includes the embodiments described with respect toFIGS. 9 and 14A-14B, such as a pinna cover 1502, an ear support 1501, amouthpiece 1516, an earpiece body 1505, and the like. Additionally, theearpiece module 1500 may contain an extension 1511 with sensors formonitoring jaw motion, arterial blood flow near the neck, or otherphysiological and environmental factors near the jaw and neck region.

The person illustrated in FIG. 15 is also wearing an earring monitor1514 according to embodiments of the present invention. Because at leastone portion of an earring may penetrate the skin, earring monitor 1514may contain sensors and telemetric circuitry that provide access tovarious blood analytes through iontophoresis and electrochemical sensingthat may not be easily accessible by the other portions of the earpiecemodule 1500. Additionally, the earring may provide a good electricalcontact for ECG or skin conductivity.

Embodiments of the present invention are not limited to earpiecemodules. Other types of modules may be utilized that attach to otherportions of a person's body. For example, a temple module 1600 having asimilar design as the earpiece module design 100 can also be employed,as illustrated in FIG. 16. A temple module 1600 has the benefit of beingclose to physiological areas associated with stress, intracranialpressure, brain activity, and migraines. Additionally, a temple modulecan monitor physiological activity associated with the onset of astroke, such as increased or decreased blood flow and/or oxygen flow tothe brain.

FIG. 19 illustrates a sensor module, according to embodiments of thepresent invention, integrated into a telemetric Bluetooth module. Thougha Bluetooth module is used in this example, it should be understood thatother telemetric modules can be used. Telemetric modules according tosome embodiments of the present invention may operate in openarchitecture protocols, allowing multiple telemetric devices tocommunicate with each other. A Bluetooth module (including the sensormodule) according to some embodiments of the present invention isintegrated into a wearable earpiece module (i.e., module 100 describedabove). The sensor module illustrated in FIG. 19 contains one or moresensors, and is mounted onto a Bluetooth module. In one embodiment, thesensor module is directly soldered onto the Bluetooth module. In anotherembodiment, the sensor module is elevated from the Bluetooth module withspacers, and a cable or electrical wires connect between the sensormodule and the Bluetooth module. The module may be elevated inembodiments where the sensors need to be exposed to the environment. Forexample, the sensors may need to be exposed through the frontside region1106 of an earpiece module 1105 (FIG. 11), and the Bluetooth module mayfit too deeply into the earpiece module to provide sensor access to theexternal environment. In some cases, contact leads or vias may connectbetween the sensor module and an extended sensor or an additional sensormodule. This allows the extended sensor or sensor module to be flexiblymounted anywhere inside, along, outside, or about the earpiece module100. Extended sensors can be especially useful for 4-point galvanometricmonitoring of skin conductance, pulse oximetry, and volatile organiccompound monitoring.

FIG. 20 illustrates the power budget of a personal health andenvironmental monitor earpiece module, such as earpiece module 100,incorporated into a Bluecore Bluetooth module, according to someembodiments of the present invention. As illustrated, the sensorcomponents (i.e., a body temperature sensor, 2-axis accelerometer,barometric pressure sensor, humidity sensor, ambient temperature sensor,and ambient lighting sensor) account for less than 16 mW of the totaloperating power of the Bluetooth-enabled earpiece module. The BluecoreBluetooth operating power during transmission is approximately 65 mW.Combined together, the earpiece module, with all operating components,can operate with less than 100 mW of total operating power and provide afull day of sensing between recharges of typical batteries. Sensorsother than these particular sensors, can also be included with minimalincrease in operating power with respect to the Bluecore Bluetoothmodule. Pulsed sensing or “polling” of the sensors to read out data atcertain intervals can further extend battery life.

Pulse oximetry is a standard noninvasive technique of estimating bloodgas levels. Pulse oximeters typically employ 2 or more opticalwavelengths to estimate the ratio of oxygenated to deoxygenated blood.Similarly, various types of hemoglobin, such as methemoglobin andcarboxyhemoglobin can be differentiated by measuring and comparing theoptical absorption at key red and near-infrared wavelengths. FIG. 17shows a transmittance pulse oximeter 1710 incorporated into an earpiecemodule (such as earpiece module 905 of FIG. 9) with the head 1707 of theearlobe clip containing an optical source 1708 and an optical detector1709. In general, the optical wavelengths from optical source 1708 passthrough arteries or veins and are selectively absorbed by various bloodmetabolites, typically blood gas carriers such as hemoglobin. Thesemetabolites can change color in response to the incorporation or removalof various blood gases, such as oxygen, carbon dioxide, carbon monoxide,and other inhaled gases. The optical detector 1709 may contain opticalfilters to selectively detect light at key wavelengths relating to thepresence or absence of the aforementioned optical absorption bands.

Though only two optical wavelengths are shown emanating from the source1708, several additional wavelengths can be incorporated and/or replaceconventional wavelengths. For example, by adding additional visible andinfrared wavelengths, myoglobin, methemoglobin, carboxyhemoglobin,bilirubin, SpCO2, and blood urea nitrogen (BUN) can be estimated and/ormonitored in real-time in addition to the conventional pulse oximetrySpO2 measurement.

The optical source 1708 can include light-emitting diodes (LEDs), laserdiodes (LDs), or other compact optical sources. In some cases, opticalenergies from the optical sources can be guided with waveguides, such asfiber optics. In some cases, ambient light, such as room light or solarradiation, may be sufficient for the optical source 1708. In such case,waveguides may be used to couple ambient light towards the earlobe orother point of interest, Ambient light may be useful in that ambientlight may represent a diffuse optical source that is largely independentof body position, such that motion artifacts associated with body motionmay be lessened. The optical detectors 1709 can include photodiodes(PDs), avalanche photodiodes (APDs), photomultipliers, or other compactoptical detectors.

FIG. 18 shows a reflective pulse oximetry setup 1800 where reflectedwavelengths 1816 are measured, as opposed to measuring transmittedwavelengths. In the illustrated embodiment, an optical source-detectorassembly 1811 is integrated into an earlobe clip head 1807 to generateoptical wavelengths 1815 and monitor the resulting reflected opticalenergy 1816. The optical source-detector assembly 1811 contains one ormore optical sources emitting one or more optical wavelengths, as wellas one or more optical detectors detecting one or more opticalwavelengths. The epidermis 1812, dermis 1813, and subcutaneous 1814layers of skin tissue are shown in FIG. 18 for reference.

The reflective pulse oximetry setup 1817 is also suitable for measuringfluorescence from various skin or blood analytes. For example, theoptical sources and/or photodetectors may be selectively filtered tomeasure key fluorescence bands. A fluorescence approach can be appliedto, for example, the real-time monitoring of cholesterol and lipids inthe skin or blood. Though the optical techniques of FIG. 17 and FIG. 18are shown primarily over the earlobe or skin, these techniques can beintegrated with the optical physiological signal extraction technique600, described above with respect to FIG. 6, for measuring blood gasproperties at or near the tympanic membrane.

Blood hydration can also be monitored optically, as water selectivelyabsorbs optical wavelengths in the mid-IR and blue-UV ranges, whereaswater can be more transparent to the blue-green wavelengths. Thus, thesame optical emitter/detector configuration used in earpiece pulseoximetry (FIGS. 17 and 18) can be employed for hydration monitoring.However, mid-IR or blue optical emitters and detectors may be required.Additionally, monitoring the ratio of blue-green to other transmitted orreflected wavelengths may aid the real-time assessment of bloodhydration levels. Blood hydration can also be monitored by measuringchanges in capacitance, resistance, or inductance along the ear inresponse to varying water content in the skin tissues or blood.Similarly, hydration can be estimated by monitoring ions extracted viaiontophoresis across the skin. Additionally, measuring the returnvelocity of reflected sound (including ultrasound) entering the head canbe used to gauge hydration. These hydration sensors can be mountedanywhere within or along an earpiece. For example, with respect to theearpiece 905 of FIG. 9, hydration sensors can be mounted to a body 902of the earpiece, the ear support 901, the earpiece backside 906, anearlobe clip, a pinna cover 1402, an earpiece fitting 1208, and thelike. For monitoring hydration properties through the tympanic membrane,the earpiece tip 1212 of the earpiece fitting 1208 may be ideal for asensor module (such as 1213). It should be noted that other hydrationsensors can also be incorporated into a module.

A variety of techniques can be used for monitoring blood metabolites viaan earpiece module, such as earpiece module 100. For example, glucosecan be monitored via iontophoresis at the surface of the skin combinedwith enzyme detection. Blood urea nitrogen (BUN) can be monitored bymonitoring UV fluorescence in blood (through the skin) or by monitoringvisible and mid-IR light absorption using the pulse oximetry approachdescribed above. Various ions such as sodium, potassium, magnesium,calcium, iron, copper, nickel, and other metal ions, can be monitoredvia selective electrodes in an earpiece module following iontophoresisthrough the skin. The optical physiological signal extraction approach600 described above can be used to monitor glucose from the tympanicmembrane by monitoring optical reflection and optical fluorescence fromthe tympanic membrane in response to IR and blue light.

Cardiopulmonary functioning can be evaluated by monitoring bloodpressure, pulse, cardiac output, and blood gas levels via earpiecemodules, and other monitoring apparatus in accordance with someembodiments of the present invention. Pulse rate and intensity can bemonitored through pulse oximetry (described above) as well as by sensingan increase in oxygenated blood with time. Pulse rate and blood flow mayalso be assessed through impedance measurements via galvanometry near ablood vessel. Additionally, pulse rate and blood flow may be assessedthrough a fast-response thermal energy sensor, such as a pyroelectricsensor. Because moving blood may temporarily increase or decrease thelocalized temperature near a blood vessel, a pyroelectric sensor willgenerate an electrical signal that is proportional to the total bloodflow in time. Blood pressure can be monitored along the earlobe, forexample. According to some embodiments of the present invention, adigital blood pressure meter is integrated into an earpiece module, suchas earpiece 905 of FIG. 9. A compact clip, similar to 1707 of FIG. 17,containing actuators and sonic and pressure transducers, can be placedalong the earlobe, and systolic and diastolic pressure can be measuredby monitoring the pressure at which the well-known Korotkoff sound isfirst heard (systolic), then disappears (diastolic). This technique canalso be used to monitor intra-cranial pressure and other internalpressures. Blood pressure may also be measured by comparing the timebetween pulses at different regions of the body. For example, sensorsfor monitoring pulse rate and blood volume can be located in front ofthe ear and behind the ear or at the earlobe, and the time between thedetection of each pulse from each sensor, as well as the volume of bloodpassed, can be processed by the signal processor 103 into an indicationof blood pressure. Electrodes within or about an earpiece can also beutilized to monitor blood gases diffused through the skin, giving anindication of blood gas metabolism. For example, a compact Severinghauselectrode can be incorporated within an earpiece module for thereal-time monitoring of CO₂ levels in the blood, for example, through anearlobe connector, a sensor region of an earpiece fitting, or along orabout an ear support. These Severinghaus-type electrodes can also beused to monitor other blood gases besides CO₂, such as oxygen andnitrogen.

Organ function monitoring includes monitoring, for example, the liver,kidneys, pancreas, skin, and other vital or important organs. Liverquality can be monitored noninvasively by monitoring optical absorptionand reflection at various optical wavelengths. For example, opticalreflection from white LEDs or selected visible-wavelength LEDs can beused to monitor bilirubin levels in the skin and blood, for a real-timeassessment of liver health.

Monitoring neurological functioning can be accomplished via electrodesplaced at the ear, near the ear, or along another surface of the body.When such electrodes are placed along the forehead, this process isdescribed as electroencephalography, and the resulting data is called anelectroencephalogram (EEG). These electrodes can be either integratedinto an earpiece module or connected to an earpiece module, according tosome embodiments of the present invention. For example, an earlobe clip(e.g., 904, FIG. 9) can be modified to conform with EEG electrodes orother electrodes for measuring brain waves or neurological activity. Formonitoring neurological functioning, a temple earpiece (e.g., 1600, FIG.16) may also be used. Electrodes may be positioned in a temple earpieceregion near the temples of a user for direct contact with the skin. Insome embodiments, direct contact is not necessary, and the neurologicalfunctioning can be monitored capacitively, inductively,electromagnetically, or a combination of these approaches. In someembodiments, brain waves may couple with low frequency acousticalsensors integrated into an earpiece module.

A person's body motion and head position can be monitored by integratinga motion sensor into an earpiece module (e.g., 905, FIG. 9) Two suchcompact motion sensors include gyroscopes and accelerometers, typicallymechanical or optical in origin. In some embodiments, an accelerometermay be composed of one or more microelectromechanical systems (MEMS)devices. In some embodiments, an accelerometer can measure accelerationor position in 2 or more axes. When the head is moved, a motion sensordetects the displaced motion from the origin. A head position monitorcan be used to sense convulsions or seizures and relay this informationwirelessly to a recording device. Similarly, head position monitoringmay serve as a feedback mechanism for exercise and athletic trainingwere head positioning with respect to the body is important.Additionally, the head position monitoring can be used to monitor whensomeone has fallen down or is not moving.

Body temperature, including core and skin temperature, can be monitoredin real-time by integrating compact infrared sensors into an earpiecemodule, according to some embodiments of the present invention. Infraredsensors are generally composed of thermoelectric/pyroelectric materialsor semiconductor devices, such as photodiodes or photoconductors.Thermistors, thermocouples, and other temperature-dependent transducerscan also be incorporated for monitoring body temperature. These sensorscan be very compact and thus can be integrated throughout an earpiecemodule. In some embodiments, these sensors may be mounted along thebackside of an earpiece body, as illustrated in FIG. 9, where theearpiece connects with the ear canal. FIG. 10 shows an embodiment of acompact sensor 1009, such as a temperature sensor, incorporated into anearpiece fitting 1008 at the backside 906 of an earpiece body 902.Because the earpiece fitting 1008 is in intimate or near-intimatecontact with the ear canal, body temperature can be very accuratelymonitored. Signal extraction technique 600, described above, may beutilized for monitoring core body temperature via the tympanic membrane.

In some embodiments of the present invention, a pedometer can beintegrated into an earpiece module to measure the number of steps walkedduring a day. Pedometers that can be integrated into an earpiece moduleinclude, but are not limited to, mechanical pedometers (usuallyimplementing a metallic ball or spring), microelectromechanical systems(MEMS) pedometers, inertial sensor pedometers, accelerometer-basedpedometers, accelerometry, gyroscopic pedometers, and the like.

In some embodiments of the present invention, a pedometer for anearpiece module employs an acoustic sensor for monitoring thecharacteristic sounds of footsteps channeled along the ear canal. Forexample, an acoustic sensor can be integrated into an earpiece housing(e.g., 902, FIG. 9) along the backside thereof (e.g., 906, FIG. 9)and/or within an earpiece fitting thereof (e.g., 1008, FIG. 10). Thesounds generated from footsteps can be detected and analyzed with asignal processor (e.g., 405, FIG. 4) using the approach described above(i.e., 500, FIG. 5) to identify footstep sounds in the midst ofconvoluting physiological noise. In this embodiment, digitizedelectrical signals from footstep sounds from outside the body arecompared with digitized electrical signals from footstep soundstraveling through the body (and ear canal), and only the spectralfeatures associated with both types of digitized signals are amplified.This provides a new signal that contains cleaner information aboutfootsteps. Better accuracy at discriminating a true step from othersounds or motions, such as driving in a car, can be determined byanalyzing more than one sensor output through the methodology 400described in FIG. 4.

Breathing characteristics can be monitored in a manner similar to thatof acoustic pedometry (described above) in the auscultatory extractionmethodology 500. In some embodiments, an acoustic sensor in an earpiecemodule is used to sense sounds associated with breathing. Signalprocessing algorithms are then used to extract breathing sounds fromother sounds and noise. This information is processed into a breathingmonitor, capable of monitoring, for example, the intensity, volume, andspeed of breathing. Another method of monitoring breathing is to employpressure transducers into an earpiece module. Changes in pressure insideor near the ear associated with breathing can be measured directly and,through signal processing, translated into a breathing monitor.Similarly, optical reflection sensors can be used to monitor pressure inor near the ear by monitoring physical changes in the skin or tissues inresponse to breathing. For monitoring the physical changes of thetympanic membrane in response to breathing, and hence ascertainingbreathing rate, the optical signal extraction approach 600 describedabove can be employed. At least one color sensor, or colormetric sensor,can be employed to monitor changes in color associated with breathingand other health factors. In the various embodiments described herein,the location of these acoustic sensors is in or near an earpiece fitting(e.g., 1008, FIG. 10) and the sensor itself is preferably positioned ina manner similar to the sensor 1009 shown in FIG. 10.

It should be noted that some embodiments of the present inventionincorporate health sensors that do not employ chemical or biologicalreagents for monitoring various health factors. This is because suchsensors have traditionally required larger instrumentation (not suitablefor portability) and/or disposable samplers (not acceptable to most endusers). However, sensors employing chemical or biological reagents maybe incorporated into earpiece modules, according to some embodiments ofthe present invention. For example, the diffusion of analyte through theskin can be monitored electrically or optically by selective binding toenzymes or antibodies contained in the health sensors integrated into anearpiece module. In some cases, iontophoresis, agitation, heat, orosmosis may be required to pull ions from the skin or blood into thesensor region for monitoring health factors. In some cases, theseanalytes may be tagged with markers for electromagnetic, electrical,nuclear, or magnetic detection.

Caloric intake, physical activity, and metabolism can be monitored usinga core temperature sensor, an accelerometer, a sound extractionmethodology (e.g., 500, FIG. 5) a pulse oximeter, a hydration sensor,and the like. These sensors can be used individually or in unison toassess overall caloric metabolism and physical activity for purposessuch as diet monitoring, exercise monitoring, athletic training, or thelike. For example, the sound extraction methodology 500 of FIG. 5 can beused to extract sounds associated with swallowing, and this can give anindication of total food volume consumed. Additionally, a coretemperature sensor, such as a thermopile, a pyroelectric sensor, athermoelectric sensor, or a thermistor, or a tympanic membraneextraction technique (e.g., 600, FIG. 6), can be used to assessmetabolism. In one case, the core temperature is compared with theoutdoor temperature, and an estimate of the heat loss from the body ismade, which is related to metabolism.

Environmental temperature can be monitored, for example, by thermistor,thermocouple, diode junction drop reference, or the like. Electricaltemperature measurement techniques are well known to those skilled inthe art, and are of suitable size and power consumption that they can beintegrated into a wireless earpiece module without significant impact onthe size or functionality of the wireless earpiece module.

Environmental noise can be monitored, for example, by transducer,microphone, or the like. Monitoring of environmental noise preferablyincludes, but is not limited to, instantaneous intensity, spectralfrequency, repetition frequency, peak intensity, commonly in units ofdecibels, and cumulative noise level exposures, commonly in units ofdecibel-hours. This environmental noise may or may not include noisegenerated by a person wearing an earpiece module. Sound made by a personwearing an earpiece module may be filtered out, for example, usinganalog or digital noise cancellation techniques, by directionalmicrophone head shaping, or the like. The environmental noise sensor mayor may not be the same sensor as that used for the intended purpose ofwireless communication. In some embodiments, the environmental noisesensor is a separate sensor having broader audible detection range ofnoise level and frequency, at the possible sacrifice of audio quality.

Environmental smog includes VOC's, formaldehyde, alkenes, nitric oxide,PAH's, sulfur dioxide, carbon monoxide, olefins, aromatic compounds,xylene compounds, and the like. Monitoring of the aforementioned smogcomponents can be performed using earpiece modules and other wearableapparatus, according to embodiments of the present invention, in avariety of methods. All smog components may be monitored. Alternatively,single smog components or combinations of smog components may bemonitored. Photoionization detectors (PID's) may be used to providecontinuous monitoring and instantaneous readings. Other methods ofdetecting smog components according to embodiments of the presentinvention include, but are not limited to, electrocatalytic,photocatalytic, photoelectrocatalytic, colorimetric, spectroscopic orchemical reaction methods. Examples of monitoring techniques using theaforementioned methods may include, but are not limited to, IR laserabsorption spectroscopy, difference frequency generation laserspectroscopy, porous silicon optical microcavities, surface plasmonresonance, absorptive polymers, absorptive dielectrics, and colorimetricsensors. For example, absorptive polymer capacitors inductors, or otherabsorptive polymer-based electronics can be incorporated into anearpiece module (e.g., 100, FIG. 1) according to embodiments of thepresent invention. These polymers change size or electrical or opticalproperties in response to analyte(s) from the environment (such as thosedescribed above). The electrical signal from these absorptive polymerelectronic sensors can be correlated with the type and intensity ofenvironmental analyte. Other techniques or combinations of techniquesmay also be employed to monitor smog components. For example, a smogcomponent may be monitored in addition to a reference, such as oxygen,nitrogen, hydrogen, or the like. Simultaneous monitoring of smogcomponents with a reference analyte of known concentration allows forcalibration of the estimated concentration of the smog component withrespect to the reference analyte within the vicinity of an earpieceuser.

In some embodiments of the present invention, environmental airparticles can be monitored with a flow cell and a particle counter,particle sizer, particle identifier, or other particulate matter sensorincorporated as part of an earpiece module (e.g., 100, FIG. 1) orexternally attached to an earpiece module. Non-limiting examples ofparticles include oil, metal shavings, dust, smoke, ash, mold, or otherbiological contaminates such as pollen. In some embodiments of thepresent invention, a sensor for monitoring particle size andconcentration is an optical particle counter. A light source is used(e.g., a laser or a laser diode), to illuminate a stream of air flow.However, a directional LED beam, generated by a resonant cavity LED(RCLED), a specially lensed LED, or an intense LED point source, canalso be used for particle detection. The optical detector which isoff-axis from the light beam measures the amount of light scattered froma single particle by refraction and diffraction. Both the size and thenumber of particles can be measured at the same time. The size of themonitored particle is estimated by the intensity of the scattered light.Additionally, particles can be detected by ionization detection, as witha commercial ionization smoke detector. In this case, a low-levelnuclear radiation source, such as americium-241, may be used to ionizeparticles in the air between two electrodes, and the total ionizedcharge is detected between the electrodes. As a further example,piezoelectric crystals and piezoelectric resonator devices can be usedto monitor particles in that particles reaching the piezoelectricsurface change the mass and hence frequency of electromechanicalresonance, and this can be correlated with particle mass. If theresonators are coated with selective coatings, certain types ofparticles can attach preferentially to the resonator, facilitating theidentification of certain types of particles in the air near a personwearing an earpiece module. In some embodiments, these resonators aresolid state electrical devices, such as MEMS devices, thin film bulkacoustic resonators (FBARs), surface-acoustic wave (SAW) devices, or thelike. These compact solid state components may be arrayed, each arrayedelement having a different selective coating, for monitoring varioustypes of particles.

In some embodiments of the present invention, environmental air pressureor barometric pressure can be monitored by a barometer. Non-limitingexamples of barometric pressure measurement include hydrostatic columnsusing mercury, water, or the like, foil-based or semiconductor-basedstrain gauge, pressure transducers, or the like. In some embodiments ofthe present invention, semiconductor-based strain gauges are utilized. Astrain gauge may utilize a piezoresistive material that gives anelectrical response that is indicative of the amount of deflection orstrain due to atmospheric pressure. Atmospheric pressure shows a diurnalcycle caused by global atmospheric tides. Environmental atmosphericpressure is of interest for prediction of weather and climate changes.Environmental pressure may also be used in conjunction with othersensing elements, such as temperature and humidity to calculate otherenvironmental factors, such as dew point. Air pressure can also bemeasured by a compact MEMS device composed of a microscale diaphragm,where the diaphragm is displaced under differential pressure and thisstrain is monitored by the piezoelectric or piezoresistive effect.

In some embodiments of the present invention, environmental humidity,relative humidity, and dew point can be monitored by measuringcapacitance, resistivity or thermal conductivity of materials exposed tothe air, or by spectroscopy changes in the air itself. Resistivehumidity sensors measure the change in electrical impedance of ahygroscopic medium such as a conductive polymer, salt, or treatedsubstrate. Capacitive humidity sensors utilize incremental change in thedielectric constant of a dielectric, which is nearly directlyproportional to the relative humidity of the surrounding environment.Thermal humidity sensors measure the absolute humidity by quantifyingthe difference between the thermal conductivity of dry air and that ofair containing water vapor. Humidity data can be stored along withpressure monitor data, and a simple algorithm can be used to extrapolatethe dew point. In some embodiments of the present invention, monitoringhumidity is performed via spectroscopy. The absorption of light by watermolecules in air is well known to those skilled in the art. The amountof absorption at known wavelengths is indicative of the humidity orrelative humidity. Humidity may be monitored with a spectroscopic methodthat is compatible with the smog monitoring spectroscopic methoddescribed above.

When environmental factors such as the aforementioned are monitoredcontinuously in real-time, a user's total exposure level to anenvironmental factor can be recorded. When a representative volume ofair a user has been exposed to is monitored or estimated, the volumetricconcentration of the analytes can be calculated or estimated. In orderto estimate the volume of air a person wearing the earpiece has beenexposed to, a pedometer or accelerometer or air flow sensor can also beintegrated into an earpiece module. Pedometers and accelerometers can beintegrated into an earpiece module via mechanical sensors (usuallyimplementing a mechanical-electrical switch), MEMS devices, and/orgyroscopic technologies. The technologies required for these types ofpedometers and accelerators are well known to those skilled in the art.The incorporated pedometer or accelerometer (or more than one pedometeror accelerometer) is used to gage the distance a person has traveled,for use in the estimation of the volume of air to which a person hasbeen exposed, and the subsequent estimate of the volumetricconcentration of monitored analytes.

The health and environmental sensors utilized with earpiece modules andother wearable monitoring apparatus, according to embodiments of thepresent invention, can operate through a user-selectable switch on anearpiece module. However, health and environmental sensors can also berun automatically and independently of the person wearing the apparatus.In other embodiments, the person may control health and environmentalmonitoring through a device wirelessly coupled to an earpiece module,such as a portable telecommunication device (e.g., 210, FIG. 2). Forexample, health and environmental sensors in or about an earpiece modulecan be controlled wirelessly through, for example, a cell phone, laptop,or personal digital assistant (PDA).

The earpiece module 100 may be configured such that user preferences canbe “downloaded” wirelessly without requiring changes to the earpiecemonitor hardware. For example, an earpiece concerned about a heartcondition may wish to have the signal processor 103 focus on processingpulse signature, at the expense of ignoring other physiological orenvironmental parameters. The user may then use the portabletelecommunication device 210 to download a specialized algorithm throughthe web. This may be accomplished through existing wirelessinfrastructure by text-messaging to a database containing the algorithm.The user will then have an earpiece module suited with analysis softwarespecialized to the needs and desires of the user.

Health and environmental monitors, according to embodiments of thepresent invention, enable low-cost, real-time personal health andenvironmental exposure assessment monitoring of various health factors.An individual's health and environmental exposure record can be providedthroughout the day, week, month, or the like. Moreover, because thehealth and environmental sensors can be small and compact, the overallsize of an apparatus, such as an earpiece, can remain lightweight andcompact.

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. The invention is defined by the following claims, withequivalents of the claims to be included therein.

That which is claimed is:
 1. An earpiece module configured to be worn atan ear of a subject, the earpiece module comprising: at least onephysiological sensor configured to monitor subject pulse rate, whereinthe at least one physiological sensor comprises a reflectance pulseoximeter; at least one external energy sensor configured to monitortemperature, sound, or light in an environment external to the ear ofthe subject; a transceiver configured to wirelessly transmit and receivedata; a communication module comprising a microphone, a speaker, and atleast one signal processor, wherein the at least one signal processor isconfigured to process audio information received from a remote sourcevia the transceiver and to communicate the processed audio informationto the subject via the speaker, wherein the at least one signalprocessor is configured to process information in real time from the atleast one physiological sensor and the at least one external energysensor, and wherein the at least one signal processor is configured toprovide biofeedback to the subject based on signals produced by the atleast one physiological sensor; a data storage component comprising aplurality of algorithms configured to be utilized by the at least onesignal processor, wherein at least one algorithm is configured to focusprocessing resources on extracting physiological information from the atleast one physiological sensor, wherein at least one algorithm isconfigured to be modified or uploaded wirelessly via the transceiver,and wherein at least one algorithm is a compression/decompression(CODEC) algorithm; and a power source configured to supply power to theearpiece module.
 2. The earpiece module of claim 1, wherein the at leastone physiological sensor and/or the at least one external energy sensoris configured to identify the subject.
 3. The earpiece module of claim1, wherein the transceiver is configured to transmit signals from the atleast one signal processor to a remote telecommunication devicefollowing a predetermined time interval, wherein the predetermined timeinterval comprises a predetermined amount of elapsed processing time. 4.The earpiece module of claim 1, wherein the power source comprises aportable energy-harvesting power source.
 5. The earpiece module of claim1, further comprising an earpiece attachment component configured toattach the earpiece module to the ear of the subject.
 6. The earpiecemodule of claim 1, further comprising an earpiece fitting configured toconnect with an ear canal of the ear and transmit sound to the inner earand eardrum of the subject, and wherein the earpiece fitting comprisesthe at least one physiological sensor.
 7. The earpiece module of claim1, wherein the communication module is configured to communicate withthe subject via a physical force, wherein the physical force comprises asense of touch or a vibration.
 8. The earpiece module of claim 1,wherein the communication module is configured to communicatetherapeutic sounds to the subject via the speaker in response to subjectphysiological or psychological stress.
 9. The earpiece module of claim1, wherein the communication module is configured to communicate atreatment, therapy, and/or plan of action to the subject upon detectionof a physiological concern and/or an environmental concern.
 10. Theearpiece module of claim 1, wherein the communication module isconfigured to audibly or visibly alert the subject in response todetermining that the subject is meeting physiological targets orexceeding safe physiological limits.
 11. The earpiece module of claim 3,wherein the earpiece module is configured to activate or deactivate theat least one physiological sensor and/or the at least one externalenergy sensor via commands from the remote telecommunication device. 12.The earpiece module of claim 1, wherein the data storage componentfurther comprises at least one algorithm configured to monitor a habitof the subject in response to subject pulse rate information obtained bythe at least one physiological sensor.
 13. The earpiece module of claim1, wherein the reflectance pulse oximeter is configured to monitorhydration level of the subject.
 14. The earpiece module of claim 1,wherein the at least one external energy sensor is a first acousticsensor configured to monitor sound in the environment external to theear of the subject, wherein the first acoustic sensor is oriented in adirection away from the subject, wherein the at least one physiologicalsensor comprises a second acoustic sensor oriented in a directiontowards the subject, and wherein the data storage component furthercomprises at least one algorithm configured to employ anacoustic-cancellation physiological signal extraction methodology thatcompares signals from the first and second acoustic sensors to generatecleaner physiological information about the subject.
 15. The earpiecemodule of claim 1, wherein the earpiece module is configured such thatuser preferences on focusing signal processing can be downloadedwirelessly without requiring hardware changes to the earpiece module.16. The earpiece module of claim 15, wherein the data storage componentfurther comprises at least one algorithm configured to focus signalprocessing on pulse signature of the subject for monitoring a heartcondition.